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 Charging Problem (2892); Insufficient Information (3190)

Patient Problems Nerve Damage (1979); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for chronic low back pain.It was reported that the patient was having a scan done for pain from their lumbar surgery that occurred prior to their device back in 2008 and was the reason for their implant.The caller stated that the patient had pain since the surgery and hadn¿t had any traumas.The caller stated that the ins had since been removed because it stopped working and quit charging.The caller stated that they left the leads implanted.Technical services reviewed mri eligibility information.It was indicated that the patient¿s device stopped working/charging in early 2010.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received on 2019-may-31 reporting that the cause was that the device would not charge anymore.After it was taken out the patient was left with permanent nerve damage in the area where the device was implanted.The explant occurred around 2010.It was noted that the device was discarded by the health care provider (hcp).No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient reporting that the device just would not charge anymore.Further information regarding the cause of the implant not working or recharging were not provided.It was reported that the patient¿s doctor was able to take it out, but now they had permanent nerve damage where the unit was implanted.The patient weighed (b)(6) at the time of the event.It was reported that the implant was explanted in 2014 which contradicts the previous report of the device being explanted in 2010.Again it was reported that the doctor put the explanted device in the trash.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional.It was reported that the hcp is no longer involved in patient's care.No further complications were reported/anticipated.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8319039
• MDR Text Key: 135498356
• Report Number: 3004209178-2019-02691
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2020
• Date Device Manufactured: 06/03/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70