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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

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

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor it was reported that the manufacturer representative was currently intra-op for an implant and is seeing "???" when running impedances.They had reseated the lead and was seeing all blue all the way through, changed amplitude to 2.0 and 250 us and move or lights and impedance were tested and the following results were reported: running impedance at:1.0 v 410 us "???" on c and 1, c and 2, running impedance at:1.5 410 us "???" c and 0, c and 1, c and 2.They also stated that they run impedance again with pulse width reduced to 210 us: c and 0 resolved, c and 1 ???, c2 resolved , c3 resolved and 0 and 3 > 4 ,000 ohms,2 and 3 > 4,000 ohms.Pat agent did not have caller pull 8870 out to verify if it is version mmb 8870 or mmb_02 8870.Troubleshooting resolved issue and mdt representative stated that bipolar combinations at 1 v and 240 us were not out of range and was advised that as long as the bipolar combinations are within range then caller can proceed.No symptoms were reported and no further complications were noted or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.No new information.

• 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 MN 00777 1200
• MDR Report Key: 8366449
• MDR Text Key: 141067208
• Report Number: 3007566237-2019-00452
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR