MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTORESENSOR MRI; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)

Patient Problem Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received from a patient (via a manufacturer representative) with an implantable neurostimulator (ins).It was report ed that the battery drains very quickly, the recharging was too frequent, and the full charge took 5 to 7 hours.The impedance was as followed with electrode 0 as the reference: 969 ohms (electrode 1), 965 ohms (electrode 2), 1029 (electrode 3), 1051 ohms (electrode 4), 1161 ohms (electrode 5), 957 ohms (electrode 6) and 1066 ohms (electrode 7).The patient had hd programming at 500 microseconds and 480 hertz.The patient had the same problem with conventional programming at 300 microseconds and 80 hertz.The charging method by the patient was optimal.It was also noted "burn the skin while charging".Additional information reported the patient must recharge "every hours" because the ins was completely discharges.It was "impossible" to continue.

Manufacturer Narrative

This regulatory report is associated with regulatory report # 3004209178-2016-18535.

• Brand Name: RESTORESENSOR MRI
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• 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: 5936545
• MDR Text Key: 54204908
• Report Number: 3007566237-2016-03160
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

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 Expiration Date: 05/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Date Device Manufactured: 06/25/2013
• 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