MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389S-40

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

Patient Problems Headache (1880); Pain (1994); No Code Available (3191)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3389s-40, lot# va1gkt7, implanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported that the patient had a diagnosis of pneumocephalus on (b)(6) 2017.The event was stated to be related to the patient's implant procedure.The patient was seen during normal rounds and complained of the worst pain/headache they have ever experienced.At that time diagnostic imaging (x-ray, mri, ct scan etc) was performed and the pneumocephalus was discovered, with no other intracranial abnormality.The patient spent a couple extra days in the hospital for observation.A ct scan on (b)(6) 2017 showed that the pneumocephalus had resolved, and the patient had recovered without sequelae.No further complications were reported or anticipated.[refer to manufacturer report #2649622-2017-10193 for details pertaining to the reportable related event.].

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the pneumocephalus was thought to be related to the surgery and anesthesia, but the exact cause was not indicated.No further complications were reported/anticipated.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6876774
• MDR Text Key: 86640885
• Report Number: 2649622-2017-10194
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

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: 02/22/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1GKT7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/08/2017
• Date Device Manufactured: 05/03/2017
• 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): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 102