MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Low impedance (2285); Low Battery (2584); Battery Problem (2885); Impedance Problem (2950)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant product: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.(b)(4).

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the right implantable neurostimulator (ins) voltage was at 2.93v but is reading end of service (eos) and stimulation cannot be turned on.The patient was programmed with 0-2+ and has a history of normal impedance measurements; (b)(6) 2015: 618 ohms, (b)(6) 2015: 652 ohms, (b)(6) 2015: 1530 ohms, (b)(6) 2016 (eos): 1199 ohms.The patient was scheduled for surgery on (b)(6) 2016 to have the right ins and extension replaced.Follow-up revealed that health care provider (hcp) was surprised that the ins moved quickly to eos and is suspicious that there is an electrical short at, or near, the ins as there was a surprising change in the patient's impedances on the right side a few months ago.The hcp noted the patient has not experienced any clinical worsening as there is a delayed therapeutic benefit in dystonia.It was also reported that the patient fell in (b)(6) 2015.An x-ray was performed revealed there were no fractures.If additional information is received, a follow-up report will be submitted.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

Additional information received from the manufacturer representative (rep) reported that the right implantable neurostimulator (ins) was replaced.It was reviewed that the ins was showing end of service (eos) but the ins battery was at 2.91 volts.The physician thought it was the right extension that had a fracture, but when the impedance was interrogated, all values were normal and therefore the physician concluded it was an ins issue.It was reviewed that an x-ray had been done and showed no anomalies.It was unknown if palpation was done during impedance testing and it was unknown if taping of the ins was done to check for battery bouncing.

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 healthcare professional via a manufacturing representative later reported a patient whose indication for use is dystonia with bilateral globus pallidus intermediate (gpi) deep brain stimulators underwent bilateral replacement of batteries on (b)(6) 2016.The right deep brain stimulator battery had reached end of service (eos) unexpectedly following just one year of service.The right battery read 2.93v on (b)(6) 2015, 2.92v on (b)(6) 2015, 2.84v on (b)(6) 2015 and eos on (b)(6) 2016.Impedance had remained normal and fairly consistent over time.The patient had a fall on (b)(6) 2015.

Manufacturer Narrative

The implantable neurostimulator (ins) end of service (eos) or elective replacement indicator (eri) longevity was not met; the cause was unknown.The longevity estimate does not match the actual battery longevity.The battery voltage was noted to be at 2.89 volts.No visual or electrical anomalies were found with the hybrid circuit.Destructive analysis of the battery did not find any internal anomalies that would have caused premature battery depletion.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5476573
• MDR Text Key: 39560002
• Report Number: 3004209178-2016-03820
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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
• Patient Age: 00064 YR