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

Model Number	37701
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Tingling (2171); Discomfort (2330)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain via a manufacturer¿s representative (rep).The rep reported that the patient complained of a painful pocket where the ins was located.The rep noted that there was no shocking in the pocket and it hurt whether the ins was on or not.The rep also reported that the patient had the elective replacement indicator (eri) initiated.There were no fall or other issues reported that could have led to the issues.The rep reported that impedances were greater than 3,600 ohms on electrodes 2 and 3 but the ins wasn¿t programming using those electrodes.The rep reported that the device was providing good paresthesia.The rep reported that the patient complained of having tingling in the feet when stimulation was turned off.The rep reported that the patient was to have the device replaced and possibly moved to another location or buried deeper per the healthcare provider (hcp).The issue wasn¿t resolved.No further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative (rep).It was reported that the physician thought that scar tissue was providing the pocket discomfort.The eri is from normal use.The patient will be scheduled to have the device replaced and possibly relocated by the physician.No further complications were reported.

• Brand Name: RESTORE PRIME
• Common Device Name: 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
• MDR Report Key: 8471061
• Report Number: 3004209178-2019-06443
• Device Sequence Number: 1525220
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR