MAUDE Adverse Event Report: NEURO - VILLALBA PISCES-QUAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3487A-33

Device Problems Degraded (1153); Device Or Device Fragments Location Unknown (2590); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 09/08/2016

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with a neurostimulator for postlaminectomy pain.It was reported that the patient was having an implantable neurostimulator replacement and possible lead revision.The health care provider attempted to pull the lead out at the spinal incision and he met resistance.The patient present for a possible lead revision.The patient had been implanted with a competitor's battery in 2005.The surgeon suspected that the leads were still in place.The leads appeared to be implanted and connected to the competitor's extensions and battery.The surgeon attempted to replace these extensions with two of the manufacturer's extensions; however at one of the lead/extension connections, there was corrosion and he had to spend some extra time getting the extension and lead apart; after which he could see the end of the lead was corroded.He attempted to remove the lead, which partially came out.He proceeded to connect the functioning lead to the newly implanted extension and implantable neurostimulator.Impedances were normal of around 1500 ohms.In programming the patient post-operation, they were able to get bilateral leg coverage that the patient was satisfied with.The issue was resolved at the time of the report.

Manufacturer Narrative

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

• Brand Name: PISCES-QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5992213
• MDR Text Key: 56095207
• Report Number: 6000153-2016-00803
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2008
• Device Model Number: 3487A-33
• Device Catalogue Number: 3487A-33
• Device Lot Number: J0424993V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: 09/08/2016
• Supplement Dates FDA Received: 09/26/2017
• 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: 63 YR