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

Model Number 37603

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a hcp regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinson¿s dual and movement disorders.It was reported the patient was having a biopsy today (unrelated to device/therapy).The caller was able to turn the patient's left ins off but when they attempted to turn the right side off they were unable to.The caller was seeing a "?".They also saw a low patient programmer battery screen.No patient symptoms or further complications were reported as a result of this event.

• 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: 7451555
• MDR Text Key: 106264957
• Report Number: 3004209178-2018-08601
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2018
• Date Device Manufactured: 01/14/2016
• 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: 78 YR