MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems High impedance (1291); Delayed Charge Time (2586)

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

Event Type  malfunction  

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

A consumer reported via a manufacturer representative that the implantable neurostimulator (ins) was taking up to four hours to charge if the ins battery went down to 25 percent.The patient was trying to recharge when the ins battery reached 75 percent since recharging only took abound 30 minutes then.The ins was programmed using high settings and the ins had recently been checked by their health care provider (hcp).The patient had slipped twice in the past and they were stressed about the battery.Impedances were checked and high impedances were measured on the left side.Electrode pair c-0 was measured to be high at 2982 ohms.Impedances were measured to be within normal limits on the right side.The ins was typically charged for 1.3 hours every day.The ins was currently programmed to c+, 0-, 1- at 4.1v, 210 usec, and 130 hz on the left side and c+, 4-, 5- at 4.1v, 210 usec, and 130 hz on the right side.The patient's indication for use is dystonia.

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 a manufacturer representative reported that the patient did not experience any symptoms.The cause of the high impedances were not determined and the high impedances did not affect the patient's therapeutic effect.No actions or interventions were taken.The recharging issue was resolved and the high impedances would be monitored as the patient was receiving therapeutic effect.Additional troubleshooting would be done if anything changed.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6401492
• MDR Text Key: 69867056
• Report Number: 3004209178-2017-05531
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 03/22/2017

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: 04/14/2013
• 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: 03/09/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided; 03/22/2017
• Supplement Dates FDA Received: 03/22/2017; 10/02/2017
• Date Device Manufactured: 05/14/2012
• 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