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

Model Number 37602

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 07/28/2016

Event Type  Injury  

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 who was implanted with an implantable neuro stimulator (ins) for essential tremor.The patient reported an elective replacement indicator (eri) and wanted to know what the eri meant.Patient stated that they did not know what they got near but it shut off, patient did not remember the date but thinks it was because they had to go to a police station and walked through one of those things, further stating that they think that had to be what shut the device off because it was out of the ordinary when it happened.Patient stated it was almost two years ago after that was when it shut off.Patient was also dissatisfied with longevity of the ins , further mentioning that before their implants always lasted like four years and this one did not even last two years.Patient saw an eri on (b)(46 and the device was replaced in (b)(6) 2016.Patient was also dissatisfied with longevity of the ins , further mentioning that before, their implants always lasted like four years and this one did not even last two years.No patient symptoms were reported.

• 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: 7587071
• MDR Text Key: 110621812
• Report Number: 3004209178-2018-13073
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 07/02/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR