MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
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 healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the adapter was broken during replacement.No environmental/external/patient factors were thought to have led or contributed to the issue.No diagnostics/troubleshooting was performed.The adapter was replaced with a new adapter right away.The issue was resolved at the time of the report.The patient was alive without injury at the time of the report.
Additional Manufacturer Narrative
Adapter pli system reported on ins based on additional information received.Concomitant medical products: product id 64002, lot# n567217, implanted: (b)(6) 2016, explanted: (b)(6) 2019, product type adapter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a rep indicated the cause of the damaged adapter was unknown.It was noted the old adapter found the old adapter was damaged when replacing the ins.

• Brand Name: NA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8302430
• Report Number: 3007566237-2019-00275
• Device Sequence Number: 1064255
• Product Code: MHY
• UDI-Device Identifier: 00613994544957
• UDI-Public: 00613994544957
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2019
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: N567217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR