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

Model Number 37601

Device Problems Unexpected Therapeutic Results (1631); Low impedance (2285); Low Battery (2584); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported seeing an elective replacement indicator (eri) code the day prior to the report.It was stated that the voltage had already dropped more and said that the patient was a battery expert, and they thought it was going to deplete faster than the doctor said.It was noted they wanted to expedite the hospital getting the replacement battery.It was further reported they felt there were unusual events occurring with eri.It was stated they noted that the voltage began decreasing and saw eri message, but all of sudden the ¿voltage jumped up to a number today, second day in a row jumped up again, but still getting the eri indicator¿ which the patient felt was unusual and believed it was a short in the circuitry.It was indicated that the patient already had surgery scheduled for (b)(6) 2017 to have the implantable neurostimulator (ins) replaced due to eri.Additional information received from the manufacturer representative (rep) reported the ins was replaced (b)(6) 2017.The ins was near end of life but issue of voltage was reported above trip point.The voltage was 2.65.It was unknown if the ins was turned off and then on when tripped.The rep indicated the patient was high parameter voltage of 4.8.It was noted the ins had been disposed and unable to be returned.The patient was implanted for parkinson¿s dual.

Event Description

Additional information received from the patient via the manufacturer representative (rep) reported that they did not turn the battery off at all.The cause of the eri and rebounding back to 2.64 remaining voltage at the time of replacement was not determined.

Event Description

Additional information was received from the patient.It was reported that the battery was faulty and no changes were made that may have contributed to the eri message.The patient reported it felt like they had a small explosion in the battery, which they believed was when the battery voltage increased to a higher level.It was stated that during the whole battery history it did not respond like the past battery.It was noted that the patient¿s ins replacement had taken place and resolved the issue.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6271090
• MDR Text Key: 65526139
• Report Number: 3004209178-2017-01500
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Date Device Manufactured: 04/15/2015
• 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: 67 YR