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

Model Number B35200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pocket Erosion (2013)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a battery placed, was closed and when the physician removed the drape to check the site, the ins was exposed at the lateral side of the battery.They said this was due to the patient being elderly and frail.A new ins had to be placed since the sterility was compromised.The new ins was placed more laterally in check and tacked down to the fascia.

• Brand Name: PERCEPT
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11201506
• MDR Text Key: 227757729
• Report Number: 3004209178-2021-01024
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• 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: Physician
• Type of Report: Initial
• Report Date: 01/20/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 01/20/2021
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR