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

Model Number 37601

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Spasm(s) (1966); Discomfort (2330); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of the event (b)(6) 2019 is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding patient who was implanted with an implantable neurostimulator (ins) for essential tremors and movement disorders.It was reported that since patient had gallstone surgery on (b)(6), they have had sudden intermittent "zing" sensation below the battery site.It was also stated that the patient's tremor has become increasingly bothersome.Rep said therapy was turned off for the gallstone procedure and they thinks lithotripsy was used.Palpation of the area gives the zinging sensation at times but not others.Rep isn't able to turn therapy off to try palpation, since patient can't tolerate therapy being off.Impedance check didn't show any apparent issue with the system.Left side programming 0- 1- 3+ c0 1375 ohms c1 912 c2 804 c3 897 01 1792 02 1797 03 1931 12 1244 13 1451 23 1206 right side programming 8- 9- 11+ c8 1345 ohms c9 1255 c10 1160 c11 897 8<(>&<)>9 1788 8<(>&<)>10 2052 8<(>&<)>11 1857 10<(>&<)>9 1731 11<(>&<)>9 1726 11<(>&<)>10 1355 ohms rep said implant battery was still at 2.9 something volts, and there was no apparent drain.Rep stated the health care provider (hcp) was thinking of replacing the ins to see if the issue resolves.Rep indicated that they knew patient had a problem with device on tuesday, but didn't know what it was until yesterday.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that they had an appointment with the surgeon and they determined that it may be a muscle spasm as it appeared to be below the ins.The surgeon ruled out the ins as the cause of the patient's discomfort.

• 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: 9530578
• MDR Text Key: 176609858
• Report Number: 3004209178-2019-24534
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: 02/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/25/2020
• Date Device Manufactured: 08/14/2018
• 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: 74 YR