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

Model Number 37612

Device Problem Low impedance (2285)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical devices: product id: 37612, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that following an implantable neurostimulator (ins) replacement, the low impedances that were noted prior to the replacement continued to occur; the bipolar pair 0 + 3 had an impedance of 37ohms while all other pairs were within the normal rage.It was noted that the cause of the impedances was unknown.It was confirmed that the connection to the battery was ok and the patient was receiving effective therapy.No symptoms were reported.

Event Description

Additional information received reported the short had first been noticed on (b)(6) 2016 when the implantable neurostimulator (ins) was interrogated during surgery.The original battery had displayed the same short.It was confirmed the patient was receiving sufficient therapy with the short so the new ins was implanted.No further troubleshooting was performed upon replacing the ins.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5690820
• MDR Text Key: 46266208
• Report Number: 3004209178-2016-10627
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided; 06/06/2016
• Supplement Dates FDA Received: 06/30/2016; 09/22/2017
• Date Device Manufactured: 11/25/2015
• 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 Age: 55 YR