MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 06/01/2017

Event Type  Injury  

Event Description

A health care provider (hcp) reported via a manufacturer representative that the implantable neurostimulator (ins) reached end of service (eos) before being implanted for nine years.The ins was currently implanted and out of service.There had been one overdischarge since implant, but the cause of the ins reaching eos was not determined.Troubleshooting included interrogating the ins and measuring impedances.No actions or interventions were taken and it was unknown if any intervention was planned.The issue was not resolved.The patient was alive with no injury.No further patient complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information received from a health care provider (hcp) via a manufacturer representative reported the patient did not experience any specific symptoms besides therapy stopping.The cause of the issue could not be determined.The hcp indicated that only one overdischarge occurred previously.No past implantable neurostimulator (ins) printouts were available and impedances were measured to be normal.A revision was done and the ins was explanted and replaced.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative reported the end of service (eos) message was displayed on the re charger, patient programmer and clinician programmer.The patient was able to recharge the ins.The patient's indication for use is dystonia.

Manufacturer Narrative

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

Event Description

Additional information received from a health care provider (hcp) via a manufacturer representative reported the revision was done on (b)(6) 2017.The patient was doing fine and they were alive with no injury.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 6820505
• MDR Text Key: 83646223
• Report Number: 3004209178-2017-18130
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2017

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: 07/28/2014
• 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: 08/22/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 08/22/2017; 09/14/2017; 10/06/2017
• Supplement Dates FDA Received: 08/25/2017; 09/18/2017; 10/09/2017
• Date Device Manufactured: 09/09/2013
• 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 Outcome(s): Required Intervention