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

Model Number 37603

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 06/12/2018

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 movement disorders.It was reported that patient just had one of their batteries replaced in (b)(6) 2018 due to normal battery depletion, and went to the neurologist yesterday.Patient was told that their battery was extremely low and patient inquired if it was possible that they got a bad battery because it is only been 6 months.It was reviewed for the patient that the battery longevity depended on usage and settings and the health care professional (hcp) may perform an estimated longevity calculation.Patient had the same settings as previously.Patient inquired if the manufacturer would replace battery if it was bad.Patient stated 6 months of having the device implanted, there should be more voltage left on it according to their past experiences.Patient stated it was difficult for them to determine how long they had left on the battery because it was low.Patient also stated that they had a dozen devices.It was reviewed for the patient that after the device is explanted , the hcp may send battery back to the manufacturer and request for analysis to be done.Patient mentioned that the hcp was going to check the programming on their device.Patient reported that yesterday the hcp checked the impedance on the device for open and short circuits and there was no issue.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) , (b)(4) determined that the ins battery was at normal end of life and telemetry/output were ok.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: 7602281
• MDR Text Key: 111160171
• Report Number: 3004209178-2018-13455
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• 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,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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: 55 YR