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

Model Number 37603

Device Problems Break (1069); Overheating of Device (1437); Pocket Stimulation (1463); Battery Problem (2885)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable information is: product id 37603, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.

Event Description

A healthcare provider (hcp) reported that the patient is experiencing muscle spasms in their back which they believe is related to the patient's chronic parkinson's as of "years" prior to date notified.It was stated that the patient is also experiencing pocket paresthesia and burning as of about six months prior to date notified.The issue can be reproduced when turning the amplitude up over 3.5v, and the patient just had their implantable neurostimulator (ins) replaced on (b)(6) 2016 which didn't correct with impedances remaining the same.Group impedance measurements were taken results of 366 ohms and 8.1 ma, with the patient programmed at 2v, 60pw, 130hz, 2-, c+.There were no falls or trauma related to this event, and an x-ray was taken which did not show any issues.The patient's indication for implant is parkinson's dual and movement disorders.See related regulatory report 3004209178-2016-22436.

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

Additional information received from the hcp via the manufacturer representative (rep) reported that impedances of the lead were measured during revision on date notified which were found to be normal.There were no out of range measurements prior to surgery but were on the low normal range of 450-1300 ohms.The extension and ins were replaced at the request of the hcp, and following revision impedances were in the 900-2000 ohm range.It was stated that the physician assistant was concerned about the rate the ins had drained since the sep-(b)(4) as it had dropped to 2.96v, which is why the replacement was suggested.The issue was resolved at the time of additional information.See related regulatory report 3004209178-2016-22436.

Manufacturer Narrative

(b)(4).

Event Description

See related regulatory report 3004209178-2016-22436.

Manufacturer Narrative

Analysis of the extension s/n (b)(4) confirmed the allegation by showing that the cause of the issues as a breached depression in the outer insulation of the device.

Event Description

See related regulatory report 3004209178-2016-22436.

Manufacturer Narrative

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

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2016, product type: extension.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer indicating that the patient's ins and extension were replaced because there was an issue with the extension that was causing the ins to deplete quickly.They think it was an extension break.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6053442
• MDR Text Key: 58313181
• Report Number: 3004209178-2016-22437
• Device Sequence Number: 1
• Product Code: MHY
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2018

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: 04/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 04/20/2017; 02/12/2018
• Supplement Dates FDA Received: 12/27/2016; 04/20/2017; 04/20/2017; 09/26/2017; 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• 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 Age: 60 YR