MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 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 04/07/2015

Event Type  malfunction  

Event Description

The representative was getting '???' on her unipolar pairs while testing impedances during implant on the day of this call.Representative changed the electrode impedance parameters the question marks would show up sometimes for some unipolar contacts and then not other times.They were unable to find settings that eliminated the question marks while on the phone.They tested and 2 and 3 showed in the low 2000's and then showed up >4000ohms during another impedance test.It was noted that they tried stimulating patient and patient felt stimulation in the bicycle seat area at 4.4 v with motor response (0-3+).Representative confirmed set screw firm, lead in place and no irrigation of system done yet.The health care provider was going to open a new battery.It was reported about 2 weeks later that the impedance issue was not determined but was device related because when we used another battery the impedance came back all under 4000 with no ????.There was no lead fractured noted.The lead was taken out of the battery and placed again.The amplitude was increased to 2 and the pulse width to 300.The patient was doing good.A follow-up report will be sent if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id: 3058, serial# (b)(4), product type: implantable neurostimulator.Product id: 3889-28, lot# va0td12, implanted: (b)(6) 2015, product type: lead.Product id: neu_ptm_prog, product type: programmer, patient.(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4736526
• MDR Text Key: 5709792
• Report Number: 3007566237-2015-01142
• 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
• Report Date: 04/07/2015

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: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/29/2015
• 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 Age: 00077 YR