MAUDE Adverse Event Report: MEDTRONIC, INC. RESTORE RECHARGER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97754
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported the ins recharger (insr) started making noises and acting crazy like it had before.The patient stated they were attempting to reset the insr to resolve the issue, but the screwdriver slipped in their hand.The patient stated they have limited functionality with their hands because of their complex regional pain syndrome from previous back surgeries unrelated to the device.The patient stated removing the screw was difficult for them, and when the screwdriver slipped, it stabbed their right thumb and there was blood all over the place.The patient spent the night in the emergency room and they needed stitches.The patient mentioned the screw could be larger with a larger hole to reset the device.Additional information was received from the patient.It was reported that the patient had to go to their neighbor's on (b)(6) 2017 to reset their insr 13 times.The patient was very upset that the field staff had not contacted them and was speaking with an attorney.No further complications are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer¿s representative (rep).The rep reported that the patient was on her fifth recharger and it was beeping.It was reviewed that the patient should plug in the recharging system to the wall while charging her device.No further complications were reported.

• Brand Name: RESTORE RECHARGER
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6876441
• Report Number: 2182208-2017-01452
• Device Sequence Number: 18956658
• Product Code: LGW
• UDI-Device Identifier: 00643169585928
• UDI-Public: 00643169585928
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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 Model Number: 97754
• Device Catalogue Number: 97754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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: 56 YR