MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3389S-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product id: 3389s-40, lot# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the 400 hotline regarding a patient who was implanted with a neurostimulator.It is unknown who initially reported the event to the 400 hotline; follow-up is being conducted to obtain clarification.It was reported that during the procedure on (b)(6) 2018, the patient began to hemorrhage, so the lead(s) were replaced.It is unknown if one or two leads were implanted and replaced so follow-up is being conducted to obtain clarification.The cause and what troubleshooting that was performed related to the event was stated to be unknown.It was then confirmed that the hemorrhage had been stopped, but the patient remained in observation.The hospital was in possession of the device(s) and it was unknown if it/they will be returned.The event was considered resolved at the time of this report.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information reported that the manufacturer representative (rep) was the first person to report the event.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7230474
• Report Number: 2649622-2018-00083
• Device Sequence Number: 1212150
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1HSUM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/21/2018
• 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: Other