MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the battery had prematurely depleted.The battery had reached end of service in early (b)(6) 2014, which was indicated to be ¿early.¿ while testing impedances, the patient experienced a shocking sensation.Impedances were noted to be ¿ok¿ however.Pain and less than 50% therapy relief were noted as symptoms.A replacement was required as a result, but had not yet been performed.A follow up report will be sent if additional information is received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Device information was updated.Analysis of the implantable neurostimulator (ins) found no significant anomaly.The ins battery was at normal end of life and t elementary and output were okay.The battery reached end of life normally.The longevity estimate is 18.15 months to elective replacement indicator (eri) and 21.15 months to end of service (eos).According to the trace report the ins reached eri in 18.50 months and eos in 21.73 months.The manual states that "the electrode impedance measurement delivers a short sequence of pulses to each possible electrode pair, one after another.This can potentially cause transient unexpected effects.", which would explain the shocking/jolting.

Manufacturer Narrative

Concomitant: product id neu_unknown_lead, product type lead.(b)(4): analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information received indicated that the implantable neurostimulator and lead had been explanted.

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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz MN 1131 ; CH 1131
• 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: 4220653
• MDR Text Key: 4975585
• Report Number: 3007566237-2014-03208
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2012
• 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