MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Material Frayed (1262); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).Analysis of the desktop charger (serial #: (b)(4)) revealed that the connector pin was damaged and the cord was frayed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the "triangular piece" of the desktop charger (dtc) was "not registering in" the implantable neurostimulator recharger (insr).The patient initially stated they were getting "only" 3 coupling boxes when attempting to charge their insr and could not charge their ins, but then clarified this was due to the dtc connector pin being broken and the cord being damaged, therefore they couldn't charge their insr.The dtc cord "tubing" was stated to be "coming undone" and it was stated the "red part" of the wires were showing.It was stated the dtc connector pin was also stuck inside the insr, and the patient was unable to remove it.Due to not being able to charge the ins, the patient stated they had "tremors to beat the band" and that they had a loss of therapy.The patient was unable to get up to access the dtc at the time of the call for the serial number.It was then clarified the dtc connector pin was bent, but it was not broken off or stuck in the insr.The dtc cord was frayed, as reported.A replacement was sent.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 9856790
• MDR Text Key: 184176444
• Report Number: 3004209178-2020-05730
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2020

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: 12/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2013
• 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