MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Anxiety (2328); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

Initially, information was received from a friend / family member regarding a patient who was implanted with a neurostimulator for parkinson's dual.It was reported that the patient was implanted on (b)(6) 2015 and recently, the patient began experiencing jittering and trembling, which was severe.It was also noted that there was not more than a 50% reduction of symptoms.The cause and what troubleshooting was performed were stated to be unknown.An appointment for programming was going to be made.The issue is ongoing.Additional information received from the representative reported event date was unknown the patient just stated ¿recently,¿ it was unknown if any diagnostics were performed, actions/interventions were noted as reprogramming, and the issue had resolved.Information received indicated that the device was implanted two years after its use before date.There were no further complications reported and/or anticipated.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

The device information was updated.Device used for off-label indication.The indication the device was used for was mhy.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 6621077
• MDR Text Key: 76957096
• Report Number: 3004209178-2017-11853
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970004
• 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,Followup
• Report Date: 06/30/2017

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 Expiration Date: 01/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/30/2017; 06/30/2017
• Supplement Dates FDA Received: 06/20/2017; 06/20/2017; 06/30/2017; 10/04/2017
• Date Device Manufactured: 08/04/2015
• 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