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

Model Number	37085-40
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis identified that the conductor(s) was/were broken less than 5 cm from the proximal end.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient was scheduled for a normal ins battery depletion replacement.The rep said when she interrogated with her tablet, a normal home screen appeared and impedance attempted to check, reports checking impedance took a long time, but was not able to check.There was no message seen.She tried a different tablet and continues not be able to connect.Caller reports on the report created by the first tablet, ins voltage was 2.2v.Reviewed eos estimated longevity performed: left side 1.3.8v/60pw/90hz.C+2- 2.2.0v/60pw/90hz.C+3- right side 1.3.8v/60pw/90hzc+ 10- 2.2.0v/60pw/90hz c+ 11- on 24/7 eri: 3.22 years and eos: 3.47 years.The caller provided additional information that even after rebooting their tablet, ins would not connect and ins would not connect to 37642.Caller stated the first interrogation attempt that ultimately didn't finish generated a session report that showed eri and 2.2v and that stim was on at beginning and end of session.When in the or, caller successfully connected to the 37601 (after completing initial impedance check) which showed that ins was off (caller reported they never turned ins off) and voltage was 2.35v.Caller attempted to run therapy impedance but ins disconnected and therapy measurement didn't finish.Caller stated that after surgery, all impedances were in range and everything was good with the patient.Caller has ins to return.Intra-op, it was determined that the right extension was replaced due to high impedances.The impedances were shows as below: c-9 14.4k 8-9 14.6k 9-10 15.1k 9- 11 15.5k the extension had to be cut when it was explanted but no pieces were left in the patient.After surgery, all the impedances were in range and there were no issues.The high impedances occurred while the old ins was connected- after replacing ins (before replacing extension) high impedances still occurred.After replacing extension wire (right side) impedance issues cleared.The cause of the tablet not connecting to the ins to complete an impedance check was not determined.The rep tried connecting with two tablets with no success on either.The patient programmer was also unable to connect to the ins.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11348482
• Report Number: 2182207-2021-00282
• Device Sequence Number: 3439954
• Product Code: MHY
• UDI-Device Identifier: 00613994353542
• UDI-Public: 00613994353542
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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 Model Number: 37085-40
• Device Catalogue Number: 37085-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1