MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 06/30/2010

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from healthcare professional of a clinical study. It was stated that on (b)(6) 2015, patient reported the device had been off as the patient programmer had malfunctioned and required return to manufacturer. Specific issue with programmer was no documented. Patient has had the device off as a result of malfunction. On (b)(6) 2015 patient reported the difficulty was with the charging system and reported they will contact manufacturer for assistance. On (b)(6) 2015, patient's device was on and was able to be reprogrammed by manufacturer representative. The actions/intervention taken were not recorded. The device was reprogrammed after therapy suspension for 3 months. It was unable to achieve improved coverage/pain relief with programming. On (b)(6) 2015, patient reported minimal relief with stimulation/decreased therapeutic effect, patient utilized the device often with minimal relief. On (b)(6) 2015, patient reported no relief with device and requested an explant. Patient was encouraged to schedule reprogramming session. On (b)(6) 2016. Manufacturer representative confirmed patient's device was permanently depleted, unable to recharge and requiring replacement. The entire device system was explanted, but not replaced, on (b)(6) 2016. No further complications were reported as a result of this event.

Manufacturer Narrative

In manufacturer's report (mfr) # 3004209178-2018-10883, it was reported that there were high impedances and the patient had their system explanted. It was corrected by the healthcare provider that the high impedances were reported in error and the system explant was previously reported. Additional review indicates the information related to the system explant pertains this mfr # 3004209178-2016-26197; any additional information related to the system explant will be reported under this mfr. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 37752 lot# (b)(4) implanted: explanted: product type recharger product id 37754 lot# serial# (b)(4) implanted: explanted: product type recharger product id 3778-60 lot# (b)(4) implanted: (b)(6)2010 explanted: (b)(6)2016 product type lead product id 3778-60 lot# (b)(4) implanted: (b)(6)2010 explanted: (b)(6)2016 product type lead product id 37743 lot# (b)(4) implanted: explanted: product type programmer, patient product id 37752 lot# (b)(4) implanted: explanted: product type recharger product id 37743 lot# (b)(4) : product type programmer if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional (hcp) on august 5th reported the patient charging system malfunction. Additional information from the hcp on august 7th reported the recharge process was related to subject non-compliance, the patient chose not to recharge. There were no further complications that have been reported as a result of this event.

Event Description

It was reported that the implantable neurostimulator recharger (insr) was not working. There was a communication problem reported. The patient was advised to place the insr antenna over the implant then press the start charge button. The patient was seeing the reposition antenna screen. They had been seeing that screen for about a month. The last time the patient was able to charge the implant was about a month and a half prior. The patient had been really sick and the device had never been effective. Information regarding if the patient still had concerns with their device or therapy has been requested. Additional information was received from a health care provider (hcp) in a clinical study. It was reported that there was a loss of pain relief.

Manufacturer Narrative

Upon additional review, it was determined that the most appropriate date was (b)(4) 2016. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device analysis for ins (b)(4) revealed no significant anomaly. The ins battery had reduced capacity due to overdischarge. The ins was received with no telemetry. According to the trace report obtained from the ins after pmr recovery, the total recharge count is 131. The last recorded recharge session performed while the device was implanted occurred on (b)(6) 2000. The device was recharged for 1 hour 55 minutes and the battery charged from 3. 710v to 3. 995v. The battery discharged to the lock mode on (b)(6) 2000. Testing of the recharge function of this ins found it to be functioning normally. The ins was placed in a body temperature oven with approximately 1cm of space between the ins and the charger antenna. A normal recharge started automatically during a physician mode recharge. The recharger had full coupling and the ins recharged for 2 hours 43 minutes to an end voltage of 3. 895v. Device analysis for lead (b)(4) revealed the body conductor was broken at the titan anchor site.

Manufacturer Narrative

(b)(4).

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6165926
• MDR Text Key: 101643735
• Report Number: 3004209178-2016-26197
• 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: consumer,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2010
• 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: 12/12/2016 Patient Sequence Number: 1