MAUDE Adverse Event Report: IPG MFG SWITZERLAND ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the patient was extremely uncomfortable with the implantable neurostimulator (ins).The ins did not seem very suitable for her.It was very large and she was very skinny.She had pain in the muscles of the left side of chest right above the breast and she could not use her arm properly.She had a lot of pain in her chest.It was ¿kind of like¿ contracting her muscles when she moved her arm in certain positions.Eating and ¿stuff¿ would cause the muscle to contract and pain.The patient did not feel this uncomfortable with the last ins.It was very difficult for her and she could not eat.The patient was going to talk to her health care professional on (b)(6) 2012.Additional information received reported there was ¿very little¿ the health care professional could do to make the patient more comfortable.It was later reported that the patient¿s first operation was in (b)(6) 2012 and she had had a single ¿big battery¿ implanted but it was too big and coming out of her chest.The patient was slender.Patient had her second operation in (b)(6) 2013 and that was when 2 smaller batteries were put in her chest.It was noted that after this surgery everything was fine.Patient had devices check in (b)(6) 2013 and everything was fine then too.

Manufacturer Narrative

(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3640480
• MDR Text Key: 4285021
• Report Number: 9614453-2014-00423
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Date Device Manufactured: 10/01/2012
• 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