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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); No Device Output (1435); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that the patient saw a ¿call you doctor¿ end of service (eos) message on his programmer.He saw the message on the day of the report and was unable to adjust stimulation or get it to turn on.The patient experienced a sudden loss of therapeutic effect and stimulation.His left hand started shaking, so he grabbed the programmer to check the status and saw the message.Follow-up from the healthcare provider (hcp) reported that there was not 50% or greater symptom reduction.Reprogramming was not needed as the event was due to end of battery life.It was later reported to be premature battery depletion.Impedance testing was done and the ins showed a short on contact 1 and 3.The patient was reprogrammed in (b)(6) to these parameters and this may have been the cause of early depletion.The ins was replaced.Follow-up from the patient reported that he did have concerns with his device or therapy.The patient wanted to know why the ins had a shortage and did not last as long as the last one.This led to the patient questioning how long the new ins would last.However, he noted that new ins worked fine.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead.Product id: 3387s-40, lot# v065001, implanted: (b)(6) 2007, product type: lead.Product id: 748295, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 7482a95, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no significant anomaly.The ins was at normal end of life and telemetry and output were okay.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from a consumer reported the implantable neurostimulator (ins) lasted 13 months and they had two shorts.The consumer thought the shorts were in the connections up to their head and the fix would be replacing the leads.The consumer would rather work with what they have than replace the leads, but they were going to meet with their health care provider (hcp) in a week.A manufacturing representative was there when the ins was replaced and the patient talked to them about the shorts.The consumer stated they decided not to use the two shorts.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4143638
• MDR Text Key: 4913347
• Report Number: 3004209178-2014-18325
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2012
• 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
• Patient Outcome(s): Required Intervention