MAUDE Adverse Event Report: NEURO - VILLALBA INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3889

Device Problems Break (1069); Peeled/Delaminated (1454); Human-Device Interface Problem (2949)

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

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.(b)(4).

Event Description

Information was received from a manufacturer¿s representative (rep).The rep reported that the insulation from the lead pulled from electrode 0/proximal end during stage 2 implant.The rep reported that the lead was replaced.Additional information was received from the rep and it was reported that no cause was determined and the lead was discarded before the rep could obtain it to return it.

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

Additional information reported that patient reported when they woke up after implant surgery no one was there because the surgery took too long.Patient said the nurse handed their the box and that was it.The caller asked about wrench compatibility 3550-02 with current 3058.It was reviewed 3550-80 as the correct wrench and use cases for the 3550-02.The caller stated that they had a case where the doctor dropped a wrench and broke a lead.The caller confirmed that this event was reported but did not have the report number.A representative in vigilance requested clarification regarding this record because during follow-up with the representative claimed to have not known about a broken lead.They re-listened to the call and transcribed the quote in which the caller referred to a broken lead.The caller stated that they wanted to know which kit contained only the wrench because they did not want to have to open a full lead kit to get a wrench if needed.They stated that they were in a case where the doctor dropped the screw driver and then the rep went on to state that, they (referring to the operating md) ended up breaking the lead, so it all worked out.The caller stated that they called tech service at that time of (b)(6) 2016 to verify how to handle the scenario and that was how it was reported but she did not have the report number.

Manufacturer Narrative

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

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6231148
• MDR Text Key: 64128542
• Report Number: 6000153-2017-00002
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3889
• Device Catalogue Number: 3889
• Device Lot Number: VA10BZC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided; 01/17/2017
• Supplement Dates FDA Received: 02/14/2017; 09/28/2017
• 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 Age: 46 YR