MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	37602
Medical Device Problem Codes	High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
It was reported that patient has a bilateral ins change due to eos/eri.The following information was received: left sc showed short circuit/low imped at preop interrogation for eri battery change on monopolar c and 0 value 224 ohm.Monopolar case and 1 showed slightly high at 2623.After connected new sc imped issue at contact 0 cleared (value 304 ohms) but contact one in both monopolar and bipolar configs are all high at 12,9k monopolar and both at 13,6k bipolar.  rt sc was at eos could not run any imped test in preop.After connecting new sc see imped issue at c and 0 of 2979.Hcp was able to program around that contact and reran it a few times.The issue has been resolved.No symptoms were reported.

• Brand Name: ACTIVA
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12929379
• Report Number: 3004209178-2021-17972
• Device Sequence Number: 5761008
• Product Code: MRU
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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 Expiration Date: 06/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/03/2021
• Date Device Manufactured: 12/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male