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

Model Number	3755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
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 manufacturing representative (rep) regarding a patient with an implanted neurostimulator (ins).It was reported that the tunneling tool broke when the healthcare provider (hcp) was pulling the extensions from the subclavicular pocket to the skull incision.The dual lead attachment head broke off the passer at the threads and lodged in the cervical neck area.The hcp used large ob forceps to retrieve the broken piece with the extensions still attached in the insert slots; this prolonged the case and led to further manipulation of the extension tunnel with larger than normal instrumentation used to retrieve the broken piece.The impedances were normal once everything was connected.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Conclusion code updated from 92 to 11.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
Fdr code corrected to (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 7112133
• Report Number: 3007566237-2017-05161
• Device Sequence Number: 1182637
• Product Code: MHY
• UDI-Device Identifier: 00613994844668
• UDI-Public: 00613994844668
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/04/2018

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: 11/09/2021
• Device Model Number: 3755
• Device Catalogue Number: 3755
• Device Lot Number: N767118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/21/2017; 01/25/2018; 04/03/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/16/2018; 01/25/2018; 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR