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

Model Number 37612

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that over the last year, the implantable neurostimulator (ins) battery was depleting more quickly and the patient seemed to be charging more frequently with charging sessions taking longer.The patient noted that in the past 3 months was when they were noticing that ins battery would be at 50% instead of at the 75% they were used to.The agent reviewed how settings/usage can effect ins battery depletion rate.The patient said they had dbs for cervical/cranial dystonia that caused spasms of the eye area and said that as time had gone on, they knew that they were at the maximum safe amplitude.Patient said that they felt like their settings were pretty close to what they had been before they noticed this change.The patient said the charging holster was useless so they held the recharger antenna over ins to charge but always got all coupling bars filled in.The patient may consider trying the adhesive discs they have.The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient has hcp appointment next week and will ask hcp more info (possibly asking for recharge interval).Caller said their hcp had looked at their ins charging statistics before but they hadn't seen the hcp in about 8 months.

Manufacturer Narrative

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

Event Description

It was reported that over the last year, the implantable neurostimulator (ins) battery was depleting more quickly and the patient seemed to be charging more frequently with charging sessions taking longer.The patient noted that in the past 3 months was when they were noticing that ins battery would be at 50% instead of at the 75% they were used to.The agent reviewed how settings/usage can effect ins battery depletion rate.The patient said they had dbs for cervical/cranial dystonia that caused spasms of the eye area and said that as time had gone on, they knew that they were at the maximum safe amplitude.Patient said that they felt like their settings were pretty close to what they had been before they noticed this change.The patient said the charging holster was useless so they held the recharger antenna over ins to charge but always got all coupling bars filled in.The patient may consider trying the adhesive discs they have.The patient was redirected to their healthcare provider (hcp) to further address the issue.Patient has hcp appointment next week and will ask hcp more info (possibly asking for recharge interval).Caller said their hcp had looked at their ins charging statistics before but they hadn't seen the hcp in about 8 months.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13537449
• MDR Text Key: 286165620
• Report Number: 3004209178-2022-02078
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2022
• Date Device Manufactured: 01/30/2017
• 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: 69 YR
• Patient Sex: Male