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); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

Note that information references the main component of the system and other applicable components are: product id: 37791, serial# unknown, product type: recharger.

Event Description

A consumer reported via a manufacturer representative that they were unable to charge and recharging was taking too long.The patient had been experiencing a lot of difficulties with charging the implantable neurostimulator (ins).The patient would get two coupling boxes filled in for a little bit, but then lose all coupling.The patient had intermittent poor coupling.The manufacturer representative had tried giving the patient recharging tips, but that was still not helping.The manufacturer representative recharging equipment was tried, but the patient had the same issue.The patient had been really frustrated with charging and they had not charged the ins for two weeks.No ins pocket issues were reported and using the antenna locate feature did not resolve the issue.The patient was going to try a new antenna to see if that resolved the issue.If the issue was not resolved, the patient was going to follow up with their health care provider (hcp).The issue had started within three days of implant.Eight days later the manufacturer representative reported the patient received the replacement antenna, but they were still getting poor coupling.The ins had been fully depleted for weeks and was going to be replaced on (b)(6) 2016.The hcp thought the ins had malfunctioned.The patient's indication for use is dystonia and movement disorders.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative (rep) reported that the battery was replaced with another rechargeable device.The cause of the issues was not determined.

Manufacturer Narrative

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5915967
• MDR Text Key: 53545982
• Report Number: 3004209178-2016-17939
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

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: 01/14/2017
• 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: 08/11/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided; 09/08/2016
• Supplement Dates FDA Received: 09/27/2016; 09/25/2017
• Date Device Manufactured: 02/22/2016
• 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: 25 YR