MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Human-Device Interface Problem (2949); Positioning Problem (3009)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: unknown, udi#: unknown.All codes apply to the lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that troubleshooting was needed for an impedance issue.The caller reported that she had increased stimulation and pulse width, but she still got "???".The rep stated that she was sure the implant was in the pocket and the healthcare provider (hcp) saw the blue tip and pulled on the lead to confirm that it was secure.The rep reported that programming the case gave very little body response at 8 volts.The rep stated that she had not tried to get a body response on the bipoles.The rep reported that lead insertion was difficult since the previous hcp left the lead tip during a previous system removal.Technical services reviewed that a lead tip left behind would not necessarily cause bad impedances, but may create difficulty in getting lead to the appropriate target.The rep noted that she will make sure the ins is in the pocket for the impedance test and will try bipole programming for body response.The rep later reported that the impedances cleared up a little, and that c <(>&<)> 1 and c <(>&<)> 3 still gave her question marks but the doctor decided to leave it in.All other combinations where normal.The rep reported that they removed the left sided lead, and put a new lead on the right side.The hcp tried to many times to place a new left sided lead but they were unsuccessful in initiating any motor response on that side.No further complications were anticipated/reported.

Manufacturer Narrative

Lot number of the lead updated to va1n87p.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the patient had very good bellows at amplitudes around 2 and that they did not get great toe flexion until 8 milliamps, in response to being asked what the cause of/what actions where taken to resolve patient giving very little body response at 8 volts when the case was programmed.The rep reported that the cause of the doctor being unable to successfully initiate any motor response on the left side was unknown.The rep noted that the physician tried numerous times to place foramen needles on the left side and initiate motor responses but was unsuccessful.The patients weight and the cause of the impedance issues/ seeing the question marks remains unknown.No further complications were anticipated/reported.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7331991
• MDR Text Key: 102216864
• Report Number: 3004209178-2018-04874
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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
• Report Date: 03/21/2018

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 Expiration Date: 07/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 03/21/2018
• Date Device Manufactured: 01/22/2018
• 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: 69 YR