MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Malaise (2359)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 97754, serial# (b)(4), product type: recharger.

Event Description

The manufacturer representative (rep) reported that it was taking too long to recharge. It was reported that the recharge stats from the clinician programmer reported a 2. 9, 6 days, average of 4 coupling bars. There was a report that repositioning the antenna resolved the issue. The rep was able to get 8 coupling bars and troubleshooting resolved the issue. It was reported that the rep would work with the patient on education on coupling. No symptoms were reported. Relevant medical history includes spinal pain. On (b)(6) 2016,the patient reported they are having some charging issues with their device. They stated that they have to charge all day to get their implant fully charged, but they can¿t leave it to charge all day because the recharger shows an overheating warning message. The patient further stated that their implantable neurostimulator (ins) keeps ¿shorting out. ¿ they further explained that when they take a shower, the ins battery depletes. It was noted that the patient has been charging every 12 hours for about the past 3 months. The patient mentioned their therapy hurts when they have it on. They stated they had a fall in (b)(6) 2016, but x-rays were taken of the leads and nothing unusual was found. Additionally, the patient cannot turn their neck due to ¿anchors¿ that are in their neck. The patient also mentioned that they are on so much medication that it is making them sick. The patient was to follow up with a manufacturing representative to have their device checked. The patient was implanted for spinal pain.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6066820
• MDR Text Key: 102529998
• Report Number: 3004209178-2016-22852
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial