MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problems Break (1069); Disconnection (1171); High impedance (1291); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Shaking/Tremors (2515)

Event Date 11/15/2019

Event Type  Injury  

Event Description

It was reported that there was a loss of therapy even though there was no evidence of a battery malfunction.Lead was fractured in some way as the patient has open circuits on all their contacts on (b)(6) 2019.All impedances were above 20k ohm and most above 25k ohms.Their active contact #9 was open.The cause is unclear with no reported injury or possible traumatic event.The patient did note having a skin biopsy of a potentially cancerous lesion on the skin just above the wire a few days prior to their tremor being less controlled and trying to adjust their stimulator "out of regulation" message on their patient programmer (pp).Dbs x-rays today looked for lead fracture but none were discovered.During surgical observation on (b)(6) 2020, it was discovered the battery was completed disconnected from the distal wires and there was a complete fracture through the wires at this area (extension fracture).The extension was replaced and the issue was resolved without sequelae.

Manufacturer Narrative

Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(4), ubd: 24-sep-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• 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: 14282036
• MDR Text Key: 290681949
• Report Number: 3004209178-2022-05644
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 63 KG