MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem Shaking/Tremors (2515)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson's disease and movement disorders.It was initially reported the patient's battery was not working.The caller then clarified the patient's device was at eos, was off/disabled, and no longer providing therapy.The caller stated she was surprised the battery reached eos because the patients settings were very low and it had "literally just been 4 years".The caller reported she was under the assumption the patient was checking is patient programmer more often than he was but he started to have tremors this morning so they took the patient programmer out and saw the eos message.The caller was redirected to follow up with the healthcare professional to discuss symptoms and schedule a replacement.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7592637
• MDR Text Key: 110878849
• Report Number: 3004209178-2018-13223
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2018
• Date Device Manufactured: 01/30/2014
• 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 Age: 77 YR