MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_ENS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516); Low impedance (2285)

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

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id neu_unknown_lead lot# unknown serial# implanted: explanted: product type lead medtronic, inc.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

The manufacturer representative reported the healthcare professional (hcp) replaced the lead because the first one moved.The initial impedance showed: at 1.0 volts, c<(>&<)>0- c<(>&<)>3 was ?????, 0 <(>&<)>3<(><<)>50 ohms, 0<(>&<)>1 1016 ohms, 0<(>&<)>2 1016 ohms, 1<(>&<)>2 1049 ohms, 1<(>&<)>3 1016 ohms, 2<(>&<)>3 1016 ohms.The manufacturer representative run the impedance at 2 volts and got c <(>&<)>0 - c<(>&<)>2 was ????, c<(>&<)>3 870 ohms, 0<(>&<)>1 870 ohms, 0<(>&<)>1 870 ohms, 0<(>&<)>2 892 ohms, 0<(>&<)>3<(><<)>50 ohms, 1<(>&<)>2 1208 ohms, 1<(>&<)>3 907 ohms, 2<(>&<)>3 998 ohms.The impedance was run later again, but got similar impedance values, although c<(>&<)>0 was 369 ohms and it was ??? before.It was stated that based on impedance, 0 electrode seemed to be the contact that was shorting, thus it would be best no to use it since it could drain the battery.It was noted the patient had response on 2<(>&<)>3 electrodes.It was noted this was a trial.

Event Description

Additional information from the manufacturing representative reported that the healthcare provider (hcp) went ahead and used the lead and everything was fine, including the patient's therapy.There was no other information available.

• Brand Name: UNKNOWN EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5820407
• MDR Text Key: 50369627
• Report Number: 3007566237-2016-02730
• 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
• Report Date: 09/29/2016

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 Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• 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