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

Model Number	37022
Medical Device Problem Codes	Break (1069); Impedance Problem (2950); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 387360, lot# va1taxu, product type: screening device.Other relevant device(s) are: product id: 387360, serial/lot #: va1taxu, ubd: 24-jul-2022, (b)(4).Report source: country: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the lead could not be used normally and the resistance could not be measured.There were no external factors reported to have led or contributed to the issue.The ¿whole link¿ was checked with no problem found and the ¿cable was no problem,¿ so the lead was replaced.It was stated that a surgical intervention occurred where by the lead was replaced and the operation was completed.The issue was not resolved at the time of report.It was noted that since lead replacement resolved the issue, ¿it was concluded that the lead was broken.¿ the patient was alive with no injury at the time of report; no further complications were reported or anticipated.
Additional Manufacturer Narrative
Device evaluation: analysis of the lead found no anomalies.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE
• 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: 8383734
• Report Number: 2182208-2019-00408
• Device Sequence Number: 420633
• Product Code: LGW
• UDI-Device Identifier: 00643169513013
• UDI-Public: 00643169513013
• Combination Product (Y/N): N
• Initial Reporter Country: MG
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Model Number: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 62 YR