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

Model Number NEU_INS_STIMULATOR

Event Type  Injury  

Event Description

It was reported the patient had intermittent shorts, saw an elective replacement indicator (eri), and had the problem corrected even though the battery had a significant bounce back. No symptoms 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.

Manufacturer Narrative

Concomitant products: product id neu_unknown_ext, serial # unknown, product type extension; product id neu_ unknown_lead, lot # unknown, product type lead; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext, product type: extension. Product id neu _unknown_lead, product type: lead. Product id neu_unknown_prog, product type: programmer, physician.

• 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 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: 4300393
• Report Number: 3007566237-2014-03522
• Device Sequence Number: 1
• Product Code: MHY
• Report Source: Manufacturer
• Source Type: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2014

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/05/2014
• 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?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/05/2014 Patient Sequence Number: 1