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

Model Number 37602

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

Patient Problem Therapeutic Effects, Unexpected (2099)

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 healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The rep reported that the patient's ins was at end of service (eos) as displayed by the clinician programmer.The rep reported that last year the patient's therapy z was 800 ohms, while today at eos, the battery measured 400 ohms.The rep reported no program changes were made.The rep reported that the other side was about the same settings and the battery was still ok.The rep reported it was unknown when the patient lost therapy.The rep reported that the ins or other components would be revised if they needed replacing next week.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (rep).The rep reported the patient was having an ins and possible extension replacement surgery on 2(b)(6)2018.The rep reported that the patient's healthcare provider (hcp) suspected that the electrode or extension possessed a short circuit, causing the impedances to drop from 800 ohms to 400 ohms, thus driving higher current which would prematurely drain the ins.The rep reported that the patient had a replacement surgery on (b)(6)2018 and both the ins and extension were replaced on the right side, resolving the impedance issue.The rep reported that prior to the replacement, the therapy impedance read 494 ohms and 7.811ma.Following the replacement, the therapy impedance read 993 ohms, and 4.106ma.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (b)(4) revealed that the battery was not in new condition.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7588953
• MDR Text Key: 110676209
• Report Number: 3004209178-2018-13120
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

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: 03/28/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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 Weight: 74