MAUDE Adverse Event Report: MPRI ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number	3708660
Medical Device Problem Codes	Break (1069); Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
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 manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and deep brain stimulation (dbs) therapy indications.It was reported that during the stage 2 surgery impedance tests were ran intra-op with freshly implanted full dbs system, contacts in front channel (left) within normal limits, contact 9 & 10 in posterior channel (right) impedances "low".Diagnostics/troubleshooting included doctor loosening the set screw, impedances were still "low".Tried the same set of events again, impedances were "low".Inserted left lead into back channel, impedances 8-11 within normal limits.Disconnected right lead from extension of skull, tested lead with twistlock = impedances normal.Doctor removed both extensions from body.Re-tunneled with same left extension and new right extension.Impedances were all within normal limits.The issue is reported to be resolved at the time of event.The extension is expected to be returned for analysis.No symptoms were reported.No further complications were reported or anticipated with this event.
Additional Manufacturer Narrative
Analysis of the extension (serial no.(b)(4)) found no anomaly.(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional review identified this event should be reported for serious injury.Correct product code to mru as the patient is implanted for dystonia.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.Troubleshooting also included removing right extension from ins, cleaning it off and reinserting, but contacts 9 and 10 were still low.The etiology was considered related to device/therapy and not related to procedure.The event was resolved without sequelae on the day of surgery.The cause of low impedances was not determined.It was reported the event resulted in medical/surgical intervention to prevent life threatening illness/injury/permanent impairment to a body structure/function.

• Brand Name: ACTIVA
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9182315
• Report Number: 2649622-2019-18450
• Device Sequence Number: 447546
• Product Code: MRU
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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 Expiration Date: 09/05/2023
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 11/14/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/14/2019; 12/05/2019
• 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: 66 YR
• Patient Weight: 75