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Author Topic: Deep brain stimulator - Extension  (Read 60060 times)
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dennis100
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« Reply #180 on: May 09, 2015, 12:09:46 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that there was a fracture outside of the header block and a revision was required. A pre-operative x-ray revealed the implantable neurostimulator (ins) was flipping in the pocket and the right extension wire was twisted. The healthcare provider (hcp) decided to take the patient to surgery to replace the right extension due to high impedances and a possible extension fracture. During surgery, they could see that the ins had flipped so much that the extension had twisted the lead around the boot of the lead connection. It was unknown why the ins flipped and the patient did not even know it was. The right side ins, extension, and lead were removed due to an infection. It looked to have eroded through the skin at the lead-extension connection. No outcome was provided.

Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3389s-40, lot# va0kcf8, product type: lead. Product id: 3389s-40, lot# va0kcf8, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4736195
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dennis100
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« Reply #181 on: June 08, 2015, 05:31:45 AM »

Model Number NEU_INS_STIMULATOR
Event Date 04/10/2015
Event Type Injury
Event Description
It was reported that abnormal impedances were measured on contact 10 after connecting the extension to the implantable neurostimulator (ins). Abnormal impedances were measured on the extension on the other side. The deepest contact of the extension had abnormal impedances. Both of the extensions were replaced and impedances were then measured to be okay. The issue was resolved. There were no patient symptoms or complications associated with the event and the patient status at the time of this report was alive with no injury.

Manufacturer Narrative
Analysis of the extension (s/n (b)(4)) found the conductor on the extension body was broken less than 5 cm from the proximal end. The #0 conductor was broken 2. 8 cm from the proximal end. Analysis of the extension (s/n (b)(4)) found the conductor on the extension body was broken less than 5 cm from the proximal end. The #3 conductor was broken 2. 7 cm from the proximal end.

Manufacturer Narrative
Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4746206
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dennis100
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« Reply #182 on: June 08, 2015, 05:32:35 AM »

Model Number 37601
Event Date 04/14/2015
Event Type Injury
Event Description
It was reported that the manufacturing representative was in the operating room on the date of this report and the extension was showing high impedance readings on electrode 2 and all pairings with electrode 2 were showing greater than 40,000 ohms. Thy disconnected, wiped down at the lead/extension junction and at the extension/implantable neurostimulator (ins) junction and when they reconnected they had continued to see greater than 40,000 ohms on all pairing with electrode 2. They replaced the extension with a different one and all impedances were in normal range.

Manufacturer Narrative
Product id 37086, serial# (b)(4), implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type extension. (b)(4).

Manufacturer Narrative
Analysis of the extension found the extension body conductor was broken, #2 conductor is broken 2. 8cm from the proximal end.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4746214
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dennis100
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« Reply #183 on: June 08, 2015, 05:33:18 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the patient was scheduled for lead, extension, and implantable neurostimulator (ins) exploration on (b)(6) 2014 due to high impedances with intermittent loss of therapy. At the time of the report there were no impedance details. The exploratory surgery was to examine the connections to try and fix the high impedances or locate the issue. Two days later it was reported that the exploration case was cancelled and did not have a re-schedule date yet. The reporter did not program the patient. Additional information received reported that all combinations with the case had impedances that measured to be greater than 40,000 ohms after the implantable neurostimulator (ins) was replaced. The following impedances were measured: 0-1 = 4423, 0-2 = 6982, 1-3 = 6475, and 2-3 = 5200 ohms. Prior to the ins being replaced, impedances were measured to be the following: c-0 = 7412, c-1 = 6752, and c-3 = 8348 ohms. The manufacturing representative knew this was a lead issue because impedances were measured to be between 8000-9000 ohms when the lead was tested. The ins was in the pocket and the patient had already been closed. The ins was changed for another reason other than the impedance issue. The plan was to reseat the extension into the ins and double check the connections. Disconnecting and reinserting the extension into the ins did not resolve the high impedances. Refer to manufacturer report #3004209178-2014-13547.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # va00p3q, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type implantable neurostimulator; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3389s-40, lot # v853915, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # va00p3q, implanted: (b)(6) 2012, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4751935
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dennis100
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« Reply #184 on: June 08, 2015, 05:33:58 AM »

Model Number 37604
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3708760, serial# (b)(4), product type: extension. Product id: neu_unknown_lead, serial# unknown, product type: lead. (b)(4).

Event Description
It was reported that there was an extension issue which was noticed shortly after implant. It was first seen in brain recordings with the primary cell device and then confirmed to be a lead issue with the clinician programmer lead impedance measurements. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4752225
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dennis100
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« Reply #185 on: June 08, 2015, 05:34:41 AM »

Model Number NEU_INS_STIMULATOR
Event Date 04/20/2015
Event Type Injury
Event Description
It was reported when the extension was connected to the parkinson's disease patient's lead during implant that ¿the number 3 connector of the extension became curved¿ and that ¿the screws of all the connectors were loosened. ¿ the extension was replaced as a result of the event and the replacement extension was noted to have ¿connected normally. ¿ impedance testing was performed and found that electrode three had ¿abnormal¿ impedance values. However, it was noted that since the patient was programmed to only use electrode one, the patient¿s physician decided to leave the system implanted and continue with stimulation. Further impedance testing performed after the completion of the surgery found that all impedances involving electrode 3 were ¿40,000 ohms or greater. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant product: product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4755838
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dennis100
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« Reply #186 on: June 08, 2015, 05:35:23 AM »

Model Number 37601
Event Date 04/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0negy, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va0negy, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

Event Description
It was reported that during stage two implant the impedance values for contact 11 were high across all combinations. The doctor took out the extension and reconnected it using the labelled description regarding the wire wrap around the implantable neurostimulator (ins). The impedances normalized, but once the pocket was closed and lightly palpated, the impedance values for contact 11 were over 40,000 ohms, indicating a possible positional break in the wire at contact 11. The extension was replaced and the case went about 35 minutes to an hour over the normal time for a stage two implant. The impedances were tested throughout the entire procedure and resolved after extension replacement. The patient was alive without injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4761861
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dennis100
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« Reply #187 on: June 08, 2015, 05:36:06 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the extension was broken and had high impedances. Prior to this, the patient was doing fine with just small dosage problems of medication and they were happy with their therapy. In march 2014, the extension was replaced. After the revision, the impedances remained high at over 4,000 ohms on many electrodes. Electrodes c, 1, and 5 were working and those were the electrodes the patient was using for therapy. Impedances were measured at a higher voltage and some impedances were lowered, but several electrodes were still greater than 4,000 ohms. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4761924
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dennis100
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« Reply #188 on: June 08, 2015, 05:36:44 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3 387s-40, lot# va09wvk, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 3387s-40, lot# va09wvk, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
It was reported that there was an extension that eroded through the skin. The manufacturer representative (rep) stated the surgeon was planning on removing the whole system the day of the report. The tissue was going to be cultured even though the area didn't look infected and a new system would be implanted in three months if everything went as planned. It was later reported that the patient was doing fine.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4766252
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dennis100
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« Reply #189 on: June 08, 2015, 05:37:33 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Analysis of the extension found the body of the extension (s/n (b)(4)) was cut through and the product was segmented. Analysis of the lead (lot # va0rb07) found the conductor of the lead at the proximal end was broken and there was a short between circuits (dry conditions). Conductor #0 and #1 were broken at the connector weld sites. Circuits #0 and #1 were intermittently shorted when tested at the distal end.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension. Product id: 3389s-40, lot# va0rb07, implanted: (b)(6) 2015 explanted: (b)(6) 2015, product type lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type extension. Product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type lead. Product id: 3389s-40, lot# va0rb07 implanted: (b)(6) 2015, explanted:(b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient had a return of symptoms. The lead and extension had performance issues and there was an open circuit on one electrode with a possible short on other electrodes. The manufacturing representative stated the lead tip and extension connection could be the cause of the short. The lead and extension were replaced. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4781011
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dennis100
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« Reply #190 on: June 08, 2015, 05:38:18 AM »

Model Number NEU_INS_STIMULATOR
Event Date 04/28/2015
Event Type Injury
Event Description
It was reported that impedances of ¿>40000¿ ohms were measured on electrodes 0 and 1 following the connection of the deep brain stimulation (dbs) system. The connections and setscrews of the lead, extension, and implantable neurostimulator (ins) were all reconnected and retightened; however, there was no change in the impedance issue. The patient¿s extension was then replaced and ¿normal¿ impedances were then measured in all electrode combinations. The extension was reportedly replaced due to a ¿breakage. ¿ there was no patient injury or death due to the event and the patient ¿recovered without sequela. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), explanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4781148
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« Reply #191 on: June 08, 2015, 05:38:57 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that all of the electrodes had impedances greater than 40,000 ohms. The left lead appeared broken via impedances results and visual inspection, a couple of inches past electrode 3 moving proximally. The extensions were coiled together and twisted in the implantable neurostimulator (ins) pocket. The patient was experiencing less than 50% therapy relief. The extensions were replaced and the damaged lead was left implanted, but not programmed to provide therapy. It was unknown what caused the lead to break or what caused the extensions to coil. The patient outcome was unknown.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v875336, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 3387s-40, lot # v875336, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4787655
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« Reply #192 on: June 08, 2015, 05:39:44 AM »

Model Number 37601
Event Date 04/30/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37086, serial# (b)(4), product type: extension. Product id: 37086, serial# (b)(4), product type: extension. Product id: 37086, serial# (b)(4), product type: extension. Product id: 3387s-40, lot# va0mwrz, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0lzzk, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), product type: extension. Product id: neu_wrench_acc, product type: accessory. (b)(4). Analysis of the extension (s/n (b)(4)) found no anomaly. There was a slight bend in the distal end that was acceptable per the manufacturing inspection. Analysis of the extension ((b)(4)) found the conductor of the extension body was broken less than 5 cm from the proximal end. Conductor #1 was broken 2. 8 cm from the proximal end. Analysis of the extension ((b)(4)) found the conductor of the extension body was broken less than 5 cm from the proximal end. Conductor #0 was broken 2. 8 cm from the proximal end.

Event Description
It was reported that during a stage two implant procedure, all impedances with electrode zero were greater than 40,000 ohms on two extensions. The damaged extensions were replaced and additional tunneling added two hours to the surgery. After replacing the extensions, impedances were measured to be within normal range and the issue was resolved. During the procedure an extension was opened but not implanted because of a bend near the distal tip where the extension plugged into the implantable neurostimulator (ins). Upon visual inspection, the extensions appeared bent. The healthcare professional (hcp) was not comfortable using the extension so a different extension was used. There was no patient death or injury and the patient had recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4787763
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« Reply #193 on: June 08, 2015, 05:40:24 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/04/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37086, serial# (b)(4), implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type: extension. Product id: 3389s-40, lot# va0rr28, implanted: 2015-(b)(6), product type: lead. Product id neu_ptm_prog lot# serial# unknown implanted: explanted: product type programmer, patient (b)(4). Analysis of the extension found the conductor on the body of the extension was broken less than 5 cm from the proximal end. The #0 and #3 conductors were broken 2. 8 cm from the proximal end.

Event Description
It was reported that high impedances greater than 40,000 ohms were measured on contact three. The healthcare professional (hcp) tried disconnecting and reconnecting the extension and a different implantable neurostimulator (ins), but the issue remained the same. The hcp replaced the defective extension and it worked fine with the issue being resolved. There was no patient injury or death and the patient had recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4788852
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« Reply #194 on: June 08, 2015, 05:41:07 AM »

Model Number 37612
Event Date 05/05/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va0twje, implanted: (b)(6) 2015, product type: lead. Product id: 3389s-40, lot# va0tspd, implanted: (b)(6) 2015, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

Event Description
It was reported that during the procedure there was a high impedance greater than 40,000 ohms on contact 0. The extension was not implanted and replaced with a new one. The surgeon had to cut it in order to remove it as well. The patient was alive with no injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4796101
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« Reply #195 on: June 08, 2015, 05:41:56 AM »

Model Number 37601
Event Date 05/13/2015
Event Type Injury
Event Description
It was reported that during a stage two implant procedure to place two extensions and an implantable neurostimulator (ins), high impedances of greater than 40,000 ohms was measured. All electrode pairs on the left side with electrode one had high impedances when tested at 3v. Troubleshooting involved disconnecting and reconnecting the extension and ins, but the impedance issue remained. The extension and lead were then disconnected and reconnected, but the issue remained. Impedances were then tested directly on the lead and they were normal. The left extension was then explanted and replaced. Impedances were measured to be within normal range after the extension was replaced and the issue was resolved. The manufacturing representative and healthcare professional (hcp) were unable to visualize any damage to the extension.

Manufacturer Narrative
Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4802630
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« Reply #196 on: July 15, 2015, 10:23:18 PM »

Model Number 37601
Event Date 05/26/2015
Event Type Injury
Event Description
It was reported that during implant, the healthcare professional (hcp) had problems with open circuits on contact zero of the extension. Impedances were measured to be greater than 40,000 ohms on contact zero. When the extension was initially connected to the implantable neurostimulator (ins), impedances were measured to be fine. The hcp had wiped off all connections. The ins was then placed in the pocket and the pocket was closed. Before ending the procedure, impedances were measured again and an open was found on contact zero. The hcp opened the pocket and took the ins out. Impedances were measured to be normal with the ins sitting in the pocket. The hcp stated this usually indicated there was a positional break and it showed up when the wires were tucked in the pocket. The hcp believed the extension break was in about a 3-4 inch length that was like a transition piece between the cord wire and the stick wire. The segment where it inserts into the ins was vulnerable due to normal manipulation. The hcp replaced the extension which added about 25 minutes to the surgery. The replacement extension worked fine. There was no patient injury or death and they had recovered without sequela.

Manufacturer Narrative
Concomitant medical products: product id: 37086, serial# (b)(4), product type: extension. Product id: 37086, serial# (b)(4), implanted: 2015-(b)(6), product type: extension. Product id: 3387s-40, lot# va0uwva, implanted: 2015-(b)(6), product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va0uwst, implanted: 2015-(b)(6), product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4850634
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« Reply #197 on: July 15, 2015, 10:24:08 PM »

Model Number 37612
Event Type Injury
Event Description
It was reported the patient experienced an infection involving their implantable neurostimulator (ins) and extensions. It was further reported the infection was ¿not in the brain leads. ¿ the infection¿s date of onset was ¿sometime around the end of (b)(6) 2015. ¿ it was noted the standard procedure was to administer perioperative antibiotics, though the specific antibiotic type administered was unknown. The patient¿s ins and extensions were replaced and the patient was administered antibiotics as a result of the event. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id 37085-60, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4824432
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« Reply #198 on: July 15, 2015, 10:25:00 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead. Product id: 7482a51, serial# (b)(4) implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va06jgn, implanted: (b)(6) 2013, product type: lead. Product id: 748351, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. (b)(4).

Event Description
It was reported that the patient¿s implant was revised in 2013 and the physician removed the extension but left the lead wire in the brain. In (b)(6) 2014 the incision next to the connection kept oozing and weeping. The patient was reportedly hospitalized and given a pick line and 6 weeks of antibiotics. It was discovered that the patient had a quarter sized hole in his scalp with wires sticking out. The patient felt a crusting and oozing but didn¿t think anything of it. Culture from the parietal wound showed staph infection. It was reported that the infection perhaps remained in the lead wire that was left in. Perioperative antibiotics were given and the implantable neurostimulator and extension was removed on (b)(6) 2014 and replaced. During follow up on (b)(6) 2014 there was no drainage and the wound was healing. During follow up on (b)(6) 2015 erosion was noted over the wire. Actions required as a result of the event consisted of complete system removal. Pocket erosion and incisional wound opening was noted. The patient was noted to have ongoing symptoms. No outcomes were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4815698
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« Reply #199 on: July 15, 2015, 10:26:08 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension. There was a severed connection in the area near the ins and the ins was twisted in the pocket. The right ins was replaced since the ins was at end of service (eos). The left ins was not replaced because, the patient was not consented for an extension replacement. The patient was not having any therapy issues related to the left ins. Prior to surgery, the manufacturing representative did not do telemetry with the ins. After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3. Impedances of less than 50 ohms were measured on 0-3. The cause of the event was not determined. The left ins was turned off until the revision and the patient was experiencing symptoms on their right side. Another revision was planned on the left side to replace the extension and ins.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868358
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« Reply #200 on: July 15, 2015, 10:28:04 PM »

Model Number 3708660
Event Date 05/17/2015
Event Type Injury
Event Description
It was reported that when attempting to connect the patient¿s lead and extension that ¿insertion was difficult because there was resistance when inserting the lead. ¿ it was further reported the resistance experienced was a ¿strange feeling. ¿ a replacement extension was used at that time and the ¿surgery was completed without any problems. ¿ a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4). Device evaluation: analysis of the extension found ¿the molded rubber was pinched and cut through on the proximal edge of the #1 setscrew connector block, pushing the #0 conductor into the channel for the lead. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4814863
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« Reply #201 on: July 15, 2015, 10:28:59 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4813073
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« Reply #202 on: July 15, 2015, 10:29:43 PM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
(b)(4): product id 3708695 lot# serial# (b)(4) implanted: (b)(6) 2015, product type: extension. Product id: 3708640, serial# (b)(4) implanted: (b)(6) 2014, (b)(6) 2015, product type; extension. Product id: 3389s-40, lot# va0h307, implanted: (b)(6) 2014, product type: lead. Product id: 3389s-40, lot# va0cs7a, implanted: (b)(6) 2013, product type: lead. Product id: 37642, lot# serial# (b)(4) product type: programmer, patient. (b)(4).

Event Description
It was reported the patient had an infection and their implantable neurostimulator (ins) and extensions had been removed. The patient had symptoms of redness at the device pocket. Perioperative antibiotics were administered and the patient did not have meningitis. Antibiotics were given to the patient to treat the infection. A new ins and extension were being implanted on the day of this report. Following the ins and extensions replacement, the patient was doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4827495
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« Reply #203 on: July 15, 2015, 10:30:37 PM »

Model Number 37601
Event Date 05/18/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37086, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension; product id 3389s-40, lot# va0t66b, implanted: (b)(6) 2015, product type lead; product id 3389s-40, lot# va0t1kx, implanted: (b)(6) 2015, product type lead; product id 37642, serial# (b)(4), product type programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

Event Description
It was reported that high impedances of greater than 40,000 ohms were measured on contact nine at implant of the extension when it was connected to the implantable neurostimulator (ins). The extension was disconnected and reconnected in to the ins, but the impedances remained high. The extension was then disconnected and reconnected to the lead, but the impedances were still high. Impedances of the lead and extension were measured using an external neurostimulator (ens) and all contacts on the lead were normal, but when the extension was connected the impedances were high on contact nine. The extension was explanted and replaced. After the replacement, all impedances were measured to be in normal range.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4821006
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« Reply #204 on: August 08, 2015, 07:47:17 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported the lead and extension connection eroded behind the patient¿s ear. The extension was removed to prevent infection. No infection was present. No troubleshooting was done. The manufacturing representative thought the implantable neurostimulator (ins) was possibly removed, but they were unsure. The cause of the erosion was unknown. The patient was to be re-implanted in the near future.

Manufacturer Narrative
Concomitant medical products: product id: neu_ins_stimulator, serial# (b)(4), , product type: implantable neurostimulator. Product id: neu_unknown_lead, product type: lead. Product id: neu_unknown_lead, product type: lead. Product id: neu_unknown_ext, product type: extension. Product id: 3708660, serial# (b)(4), implanted:(b)(6) 2013, product type: extension. Product id: 3389s-40, lot# v975264, implanted:(b)(6) 2013, product type: lead. Product id: 3389s-40, lot# v975264, implanted:(b)(6) 2013, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4934940
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dennis100
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« Reply #205 on: August 08, 2015, 07:48:02 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that there was a change in therapy, patient experienced shocking. The patient had begun experiencing electrical shocks about 2-3 times over a span of 2-3 weeks in (b)(6) 2014. In (b)(6) prior to the date of this report the patient had jumped like he had stuck his finger in an outlet. They had known it was not programming and eventually the healthcare professional had done a revision of the extension on (b)(6) 2015 and had noted that it was positioned in such a way that it was crimped. Insulation was missing at the base. When the healthcare professional had gone into the extension/lead connection the lead or extension was calcified. The extension was replaced. The ¿cranial lead was yellowed and problematic. ¿ there were no falls or traumas. The change in therapy/symptoms was sudden. The healthcare professional was ¿never able to reprogram. ¿ the patient was going to have the right ventral intermediate nucleus (vim) lead replaced and possibly repositioned in the near future, scheduled for (b)(6) 2015. It was noted that the manufacturing representative was aware that the patient was having therapy concerns in regards to symptom control which the manufacturing representative felt was a programming issue. Reference manufacturer¿s report number: 3004209178-2015-13908.

Manufacturer Narrative
Concomitant products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 64001, lot# n249314, implanted: (b)(6) 2010, product type: adapter. Product id: 3387s-40, lot# v556377, implanted: (b)(6) 2010, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 64001, lot# n433611, implanted: (b)(6) 2014, product type: adapter. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 3387-40, lot# j0209882v, implanted: (b)(6) 2002, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4932846
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« Reply #206 on: August 08, 2015, 07:48:45 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the there was a possible short circuit. The physician interrogated the implantable neurostimulator (ins) after the patient reported a loss of therapy, less than 50% therapy relief at the device pocket. Impedance testing was performed. Interrogation revealed very low impedances on one side, specific values and electrodes with issue were not specified. The patient reported no event that could explain external damage to the extension or ins. The patient was hospitalized. The patient also experienced tingling sensation around the ins pocket area. The patient underwent a revision that revealed a broken extension. The extension was removed and replaced with a new one. The ins and lead remained fine in use. The case was closed. The company representative confirmed the system had been implanted for three months only. The rep could only speculate and has no real idea how this could have happened. The neurosurgeon thinks the patient have a very active immune system that attacked the extension from the very first day. The extension was very hard to extract as there was tissue grown all over the cable. The patient did not have any recent surgical intervention in the extension area. The patient was fine again after the extensions were replaced. Therapy works fine also. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id: neu_unknown_ext, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4929046
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« Reply #207 on: August 08, 2015, 07:49:41 AM »

Model Number NEU_INS_STIMULATOR
Event Date 06/19/2015
Event Type Injury
Event Description
It was reported the patient experienced ¿increasing impedance values as well as decreasing therapeutic effect¿ over ¿the course of time. ¿ it was further reported the patient had experienced a ¿gradual¿ loss of stimulation/therapeutic effect. Impedance testing was performed and found ¿high¿ impedance values. It was noted the extension had been ¿placed inferior to the m pectoralis major. ¿ the patient¿s ¿dysfunctional¿ extension was replaced as a result of the event. The patient was ¿well after replacement¿ of the extension and was alive with no injury. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant product: product id 3708640, serial # (b)(4), explanted: (b)(6) 2015, product type extension. (b)(4).

Manufacturer Narrative
Analysis of the extension found the conductor of the extension body was broken less than 5 cm from the proximal end. All conductors were broken at 2. 9 cm from the proximal end.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4902382
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« Reply #208 on: August 08, 2015, 07:50:23 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2015 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6), explanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# va0j3u3, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0e81e, implanted: 2014 (b)(6); product type lead. (b)(4).

Event Description
It was reported that the patient¿s extensions eroded through her skin at the lead location. Impedance testing was performed and the extensions were replaced. The issue was resolved, but the cause was not determined. The patient was alive with no injury at the time of the report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4899150
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« Reply #209 on: August 08, 2015, 07:51:07 AM »

Model Number NEU_INS_STIMULATOR
Event Date 06/12/2015
Event Type Injury
Event Description
It was reported that during implant, high impedances were measured on electrode three. The extension was disconnected and reconnected, but the impedance of electrode three remained out of range. The extension was replaced and a new extension was implanted. Impedances were measured to be normal with the new extension. All was well after the extension was replaced. There were no patient symptoms or complications associated with this event and the patient status at the time of this report was alive with no injury.

Manufacturer Narrative
Concomitant medical product: product id: 3708660, serial# (b)(4), implanted: 2015-(b)(6) explanted: 2015-(b)(6), product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4892149
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