MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Delayed Charge Time (2586); Charging Problem (2892)

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

Event Date 12/21/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported the patient was recharging the ins's today and both ins's got to 75% battery charge level.The patient then wanted to charge them and spent 30 minutes charging and it never changed to fully charged.The patient had good coupling while charging.The patient was expecting too much too fast for the charging.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Based on additional review of event, the initial mdr was filed as manufacturer¿s report# 3007566237-2017-03866.Based on additional information received, the correct manufacturing site was # (b)(4).It was noted that the patient had 2 implantable neurostimulators (ins) present during the event.See manufacturer¿s report # 3 007566237-2017-05295 for the concomitant ins information.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 7146303
• MDR Text Key: 96008828
• Report Number: 3007566237-2017-05294
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/07/2018
• Date Device Manufactured: 02/16/2017
• 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: 79 YR