MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Unexpected Therapeutic Results (1631); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Additional review indicated the voltage provided in related to the eri was noted to be 2.76v.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient¿s implantable neurostimulator (ins) had drained prematurely to an elective replacement indicator (eri) status.The patient had been programmed to 3.3v, 150 ¿s and 140 hz on channel 1 and 2.6v, 120 ¿s and 140 hz on channel 2.Therapy impedances were 267 ohms and 967 ohms on the respective channels.Cycling was not enabled and electrode impedances were all within normal range.With this ins, therapy had not been quite as good as one of the patient¿s previous devices.Rerogramming had been attempted several times, but to no avail.The patient was reportedly still receiving therapy, but it was ¿diminished¿.Additionally, the patient was now feeling ¿fuzzy¿ in the head.Further troubleshooting had been planned.A replacement for (b)(6) 2014 was noted.However, it was also stated that a replacement would follow if ¿lead or extension or whatever¿ was damaged.It was stated the procedure was not scheduled yet.It was ultimately unclear if the patient¿s device had been replaced, but information suggested a surgical intervention was to occur.Additional information has been requested but was unavailable at the time of the report.A supplemental report will be made available when this information is received.

Manufacturer Narrative

Product id: 3389, serial# unknown, product type: lead.Product id: neu_unknown_ext, serial# unknown, product type: extension.Product id: 64002, serial# unknown, product type: adapter.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported the patient's whole system 㠔he leads, extensions, and battery were all replaced.There was noted to have been "short circuit in the lead." the lead was not to be returned for analysis however, as the surgeon reportedly "sabotaged the extension and lead on explant." the patient was 쒅ceiving therapy" at the time of follow-up.

Event Description

Additional information received reported that additional troubleshooting was going to be performed the following day.The patient was also booked in for a re-implant that same day.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4290813
• MDR Text Key: 5275147
• Report Number: 3007566237-2014-03475
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2014

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 Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2014; 12/24/2014; 01/02/2015
• 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