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

Model Number 37601

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Scar Tissue (2060)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_tunnelingtool.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that during stage 2 surgery the physician was tunneling and the tunneler tip got caught on something.The physician started twisting the handle of the tool to break it free and the tip must have been stationary and the rest of the tool unthreaded from the tip due to the physician twisting it.When the tip reached the battery pocket there was not a tip on the tunneler.Environmental/external/patient factors that may have contributed to the issue was that the tool was stuck on something enroute to the pocket.Diagnostics/troubleshooting included an x-ray being called and they located the tip on the bottom of the patient's neck.He attempted to retrieve it with instrumentation and was unable to do so.He opened an incision on the patient's neck to get it out.The issue is reported to be resolved at the time of the report.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the tunneling tool was discarded and wouldn¿t be returned.No further complications were anticipated.

• 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: 8242333
• MDR Text Key: 132911514
• Report Number: 3004209178-2019-00835
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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: 04/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/12/2019
• Supplement Dates FDA Received: 01/22/2019
• Date Device Manufactured: 10/15/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 87 YR