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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Type  Injury  

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

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implanted neurostimulator (ins) for dystonia and movement disorders.The hcp reported that the patient is unable to charge the ins past 50%.An appointment is scheduled for (b)(6) 2017 where a manufacturer representative will go over the recharging process with the patient.No patient symptoms reported.

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

Follow up information received from the rep reported that the patient is able to get past 50% charge and understands that they need to charge a longer period of time.

Manufacturer Narrative

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.

Event Description

Additional information received from a manufacturing representative (rep) indicated the patient's battery was replaced (b)(6)2019 with a new rechargeable device in a new, shallower pocket.The day of surgery, the battery was discharged and they were unable to read or obtain coupling data.Coupling with a recharger in the or read 8 black boxes.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported it was confirmed the implantable neurostimulator (ins) had migrated and was too deep, but the cause of these issues wasn¿t determined.Due to the migration and implant being too deep a revision surgery was scheduled for (b)(6) 2019.As of (b)(6) the issue wasn¿t resolved, but it would ¿hopefully¿ be resolved after the revision.No further complications were anticipated.

Manufacturer Narrative

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.

Event Description

Additional information received from a consumer, via a manufacturing representative (rep), indicated the patient was having coupling issues with their recharging system.The rep reviewed charging with them and they were seldom able to acquire 8 blocks when coupling and more often only got 2 out of 8 blocks.It seemed the ins was too deep and the patient believed the ins had migrated from its original position.They requested neurosurgery to do an evaluation for a pocket revision.

• 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: 6233540
• MDR Text Key: 64188081
• Report Number: 3004209178-2017-00469
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/14/2020

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: 01/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; 01/13/2017; 04/24/2019; 05/10/2019; 06/21/2019; 10/14/2020
• Supplement Dates FDA Received: 02/06/2017; 09/28/2017; 05/08/2019; 05/21/2019; 07/02/2019; 10/14/2020
• Date Device Manufactured: 02/18/2016
• 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