MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97713

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative and a health care professional (hcp) regarding a patient who was implanted with a neurostimulator for failed back surgery syndrome.It was reported that the patient had a battery replacement due to regular end of service (eos) of an old implantable neurostimulator (ins).During the procedure when the pocket was opened to remove the ins, the hcp noted that the leads and a part of the ins that were normally clear were ¿yellow and opaque.¿ the hcp proceeded as normal.Loosened the screws to remove the extension form the old ins and found it difficult to pull out the old leads from the ins.The manufacturer representative was in the operating room for the procedure and advised to make sure that the screws were completely loose.With a few seconds of struggling, the leads came out of the old ins.Available information suggests that this statement was reporting that it was difficult to pull the extensions from the old ins.When trying to connect the existing extensions into the new ins, they would not slide in as normal.The hcp was again advised to ensure the screws of the new ins were loose enough to allow the leads to slide in.The hcp did so and attempted to push the leads in again.After a few minutes of trying to push the extension tips in to the new ins, the lead was only able to be put in a quarter of the way.The hcp attempted to pull the tip back out at which point the extension tip broke off in the new ins and could not be removed.The hcp then tried to disconnect the extensions from the existing leads in an attempt to connect the leads directly to a new ins.Upon trying to disconnect the extensions, the leads appeared to be ¿jammed¿ as well despite the screws for the extension being fully removed.In attempting to disconnect the leads, the tips of the leads broke off inside the extension connector.The manufacturer representative advised that the patient would need a full revision of the existing system since the current problem of broken leads was irreparable as they were.The hcp chose to close the pocket and proceed with waking the patient to explain that the replacement failed.The plan was to complete a full system explant and replacement at a future date if the patient so wished.The explanted products and new ins that could not be implanted would be sent to the manufacturer for analysis.A phone call with the manufacturer representative on 2016-04-08 reported that information was still being gathered by another manufacturer representative, but a replacement surgery was scheduled.Please see report number 3004209178-2016-07297.

Event Description

Additional information received reported the patient was going to be scheduled for a revision or replacement of the existing system.There was no set date for the replacement yet.

Manufacturer Narrative

Concomitant medical products: product id: 3708140, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 37713, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 377860, lot# v016867, implanted: (b)(6) 2007, product type: lead.Product id: 377860, lot# v016653, implanted: (b)(6) 2007, product type: lead.Product id: 3708120, serial# (b)(4), product type: extension.Product id: 3708120, serial# (b)(4), product type: extension.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.

Event Description

Additional information received from the manufacturer representative reported that the manufacturer representative had returned the only product in his possession the day after the surgery.It was noted that product was the implantable neurostimulator (ins) that was being replaced, the replacement ins that the lead broke off in and one of the extensions.

Manufacturer Narrative

Concomitant products: product id: 37713, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 377860, lot# v016867, implanted: (b)(6) 2007, product type: lead.Product id: 377860, lot# v016653, implanted: (b)(6) 2007, product type: lead.Product id: 3708120, serial# (b)(4), product type: extension.Product id: 3708120, serial# (b)(4), product type: extension.The implantable neurostimulator (ins) (serial # (b)(4)) was returned and analysis found an extension or extension parts to be stuck inside the ins connector port.The extension (serial # (b)(4)) was returned and analysis found environmentally assisted degradation of the insulation on the proximal end.The extension (serial # (b)(4)) was returned and analysis found environmentally assisted degradation of the insulation on the proximal end.(b)(4).Upon return and analysis of the extensions, it was determined that the previously reported extension serial numbers were not correct.The appropriate serial numbers for the extensions are (b)(4).All future reports will refer to the extensions with these serial numbers.

Manufacturer Narrative

Conclusion: no longer applies for the extensions.Applies to both extensions.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5571414
• MDR Text Key: 42490847
• Report Number: 3007566237-2016-01656
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00052 YR