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

Model Number B35200

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

Patient Problems Muscular Rigidity (1968); Scar Tissue (2060); Discomfort (2330); Insufficient Information (4580)

Event Date 03/21/2022

Event Type  Injury  

Event Description

It was reported that it looked like the extension was causing a bump and pressure point under the skin so they revised the pocket to relieve the tension under the skin.The extensions were scarred down in a bunch behind the battery and the way the extension was coming out of the header block, it was putting pressure in upper corner of the device.The extension wires were untethered from behind the generator and the loop coming out of the block was tucked behind the battery better.The pocket was revised to help take some of the tension off the corner of the generator.The issue was resolved at this time.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2018, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2018, product type: extension.The main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 05-jul-2022, udi#: (b)(4).Product id: 3708660, serial/lot #: (b)(4), ubd: 05-jul-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13869415
• MDR Text Key: 290160763
• Report Number: 3004209178-2022-03649
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2022

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: 10/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 03/23/2022
• Date Device Manufactured: 11/01/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG