MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Unable to Obtain Readings (1516); Low impedance (2285); Malposition of Device (2616)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 3389, serial# unknown, product type: lead.(b)(4).

Event Description

A health care provider (hcp) reported via a manufacturing representative that low impedances were measured on a lead during a follow up appointment.The patient was not getting much benefit from their system.Impedances were checked with a clinician programmer.Low impedances of 59 ohms were measured on electrode pair 0-1."???" were measured on electrode pairs c-2 and 1-2.According to post operation ct scans, the lead appeared high so electrodes 0 and 1 were the best.The hcp assumed there was a short circuit between 0 and 1.No surgical intervention had occurred and it was unknown if intervention was planned.The issue was not resolved at the time of this report.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Event Description

Additional information reported there was "no change with regards to the patient" and that the patient's "problem was still there" as of (b)(6) 2015.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 4973940
• MDR Text Key: 22416858
• Report Number: 3007566237-2015-02199
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2015
• 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