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

Model Number 37712

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Date of event was reported as (b)(6) 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.

Event Description

Information received from the patient reported that they were without stimulation from their implantable neurostimulator (ins) and was in a lot of pain. They stated had not been able to use the programmer to adjust the stimulation so they were in a lot of pain from the waist down (ins was implanted for this pain). The patient also reported they had nerve damage, pain in their ears/arms and did not take any pain medications. The indication for use for the implanted device was noted as non-malignant pain. There were no further details, troubleshooting, interventions, or an outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be submitted.

Event Description

Additional information received from the consumer reported their healthcare provider (hcp) wouldn't give them the "only pill that worked. " the consumer further reported the steps taken to resolve their pain issue was getting a new remote for "the upper but still need a cable. " the pain from the waist down was not resolved since it still hurt, "but the machine helped a lot, and i still have pain all through my body," as well as nerve damage and scar tissue.

Manufacturer Narrative

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.

• 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: 5744521
• MDR Text Key: 102099053
• Report Number: 3004209178-2016-12775
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/14/2014
• Device Model Number: 37712
• Device Catalogue Number: 37712
• 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: 08/19/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/21/2013
• 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: 06/23/2016 Patient Sequence Number: 1