MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PRIMEADVANCED; STIMULATOR, SPINAL CORD

Device Problem Premature Discharge of Battery (1057)

Patient Problems Erythema (1840); Pain (1994)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

The patient had this device placed surgically three years ago.She had an office visit with her physician at which time the medtronic vendor scanned the device and found the battery needed to be replaced within 6 months.The patient reported at the same time that the battery site is very painful and gets very hot and red.She had surgery to replace the device with a new one.The old device has been cleaned, disinfected, and sequestered.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL CORD
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 4877832
• MDR Text Key: 16898264
• Report Number: 4877832
• Device Sequence Number: 1
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2015
• Patient Sequence Number: 1
• Patient Age: 32 YR