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

Model Number	3708660
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
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 manufacture representative (rep) regarding a stage ii deep brain stimulation implant.It was reported that during the stage ii procedure, the extensions were tunneled and plugged into the primary cell battery.The initial impedance check was good with all normal values.A subsequent impedance check was done after the leads/extension and battery were fully tucked in under the skin.All combinations on contact 0 were high.Programmer read high indicating a value above 40,000.The surgeon tried disconnecting the extension from the battery and reconnected it.The high still remained on all combinations of contact 0.It was indicated that the surgeon manipulation of the extension could have contributed to the high impedance.We decided to re-tunnel and place a new extension to replace the bad one.The new extension was placed and tucked in.Another impedance check showed all normal impedance values.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the extension, (b)(4) found that the stim extension body conductor was broken less than 5cm from proximal end.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DBS¿
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8320616
• Report Number: 2649622-2019-02116
• Device Sequence Number: 1692448
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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: 09/21/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 02/25/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 02/12/2019; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 59