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

Model Number 37612

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Energy Output Problem (1431); Battery Problem (2885)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Updated to serious injury per additional information received.Estimated event date based on event information.Month and year are accurate.Activa rc 37612 is not approved for dystonia in the us.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported the patient underwent bowel surgery on (b)(6) 2020 with electrocautery using radio frequency energy.The patient was transported to the hospital in the evening due to worsened dystonia during the day.The physician found the ins off when they interrogated it, but the ins was charged to 100% and the patient recharges almost every day.The ins was turned on and the patient began to feel benefit of therapy again.All programs and settings were there and correct with stimulation at 5.5 v bilaterally.The physician started the patient at a lower amplitude of 3.5 v bilaterally and gave the patient the possibility to adjust amplitude during the night.It was noted the patient was not feeling anything strange in their body.There was no longer a por displayed when checking the programmer or recharger, and the patient was able to adjust amplitude without problems.It was noted the physician did not want to increase amplitude because of the "happening" the prior days and they did not wish to provoke a dystonic crisis.Additional information indicated the por was a parity por, and it was believed to have been the result of the (unrelated) bowel surgery.

Manufacturer Narrative

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

Event Description

It was reported there was a power on reset displaying on the insr (recharger).The stimulation efficacy is not the same as last week, but the patient was recharging the ins as usual.The patient could not find the patient programmer, so the por was not confirmed on there.Additionally, the patient could not tell if any energy was lacking on the recharger display.

Manufacturer Narrative

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

Event Description

Additional information confirmed that the patient experienced dystonic crisis as a result of the event.It was also confirmed that the ins was not turned off prior to the bowel surgery because the patient had forgotten their programmer.The event was resolved at the time of this supplemental report.

• 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: 9739537
• MDR Text Key: 182636396
• Report Number: 2182208-2020-00338
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2010
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Date Device Manufactured: 01/15/2010
• 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): Hospitalization