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

Model Number B35200

Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Electric Shock (2554); Paresthesia (4421)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient fell and hit their head on a mini fridge while they were sleeping, and when they woke up their right arm was "hurting bad" and tingling.Regarding the tingling in their right arm, the patient described it as "electricity going through it." the patient added that the sensation in the arm would occur when they turned their neck a certain way.The patient also mentioned feeling numbness in their right arm and that their balance was affected after they hit their head.Prior to this event, the patient mentioned that they used the dbs therapy app to "turn up one side a little more," but not allegations were made regarding therapy.

• 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: 12899180
• MDR Text Key: 286766971
• Report Number: 3004209178-2021-17780
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Date Device Manufactured: 10/26/2020
• 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 Age: 51 YR
• Patient Sex: Female