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

Model Number 37612

Device Problems Battery Problem (2885); Charging Problem (2892); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 05/27/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial#: (b)(4), product type: recharger.Product id: 37761, serial/lot #: (b)(4).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 and movement disorders.It was reported that the connector pin was broken, further stating that this had happened multiple times in the past.It was stated that the patient was shaky because the cord was broken, and they were unable to recharge their implant so the battery went dead.It was noted that the therapy helps when it is on but the shakiness from the patient's essential tremor returned when the implant died.Patient stated that they were going to have to zap them again, referring to recharging the patient's implant.No out of box failure was reported.The caller was warm transferred to the repair department for a replacement.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

The desktop recharger was returned for analysis.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient indicating that the replacement desktop charger resolved the implant recharging issues and the shaking has been resolved.The defective desktop charger was received for analysis.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7553685
• MDR Text Key: 109909836
• Report Number: 3004209178-2018-12142
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 07/09/2018; 08/08/2018
• Supplement Dates FDA Received: 06/19/2018; 07/19/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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 Age: 70 YR
• Patient Weight: 78