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

Model Number 37602

Device Problems Premature Discharge of Battery (1057); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); 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); Therapeutic Response, Decreased (2271)

Event Type  Injury  

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

Information was received from a manufacturing representative about a patient with an implantable neurostimulator (ins) for parkinson's dual movement disorders.It was reported that the patient¿s ins reached the end of service (eos) indicator.The patient¿s device is off, and no longer delivering therapy.The patient¿s programmed setting were given, and a longevity calculation performed.The patient¿s ins estimated lifespan was 15 months.It was stated that the eos did not seem appropriate.The electrode impedances were stated to be 895-2729ohms.It was also reported that the voltage of the ins was higher than expected at eos, stating that it was at 2.42v.The manufacturing representative stated that there was an oor message seen, and the manufacturing representative was unaware how long this may have been present.It was also stated that the patient had an mri and the patient¿s device was not turned off or acknowledged by the mri technician.The manufacturing representative reported that the patient said the system was acting ¿funny¿ which is why they had the mri.The caller reported that they will review ins replacement, and send the ins in for analysis after revision.The issues reportedly began in (b)(6) 2016.No further complications reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the ins reached eos prior to one year.The mri was performed in november 2016 because it was not working right from the start.The patient's therapy was never as good as with their previous ins.The ins was explanted and replaced.

Manufacturer Narrative

Corrected information: sex, date of birth if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis product id# 37602: a longevity estimate was calculated using available parameter information, and the ins did not meet expected longevity.During destructive analysis, the battery portion of the ins did not indicate any internal anomalies that would have caused premature depletion.The cause remains unknown.Fdc code 22 replaces previous codes of type.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6578184
• MDR Text Key: 75545949
• Report Number: 3004209178-2017-10660
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2016
• 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: 67 YR