MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY VERSITREL; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427V

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

Patient Problems Respiratory Distress (2045); Chest Tightness/Pressure (2463)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 3998, lot # j0437018v, implanted: (b)(6) 2004, product type lead; product id 748940, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 748940, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 7435 , serial # (b)(4), implanted: (b)(6) 2004, product type programmer, patient.(b)(4).

Event Description

The manufacturer representative (rep) reported that the patient had pressure on the chest and difficulty breathing when the implantable neurostimulator (ins) was on.The stimulation therapy (right below the knee) was working correctly even when she felt the pressure on her chest.The cardiologist did not find any problem.It was noted that the ins was implanted in the right buttock and the lead was at t10.Additional information received on 2008-jun-03 from the rep in response to follow-up reported that the patient was reprogrammed and she was fine.Additional information received on 2008-nov-13 from the healthcare provider (hcp) reported that an explant occurred.Relevant medical history included arachnoiditis.

• Brand Name: SYNERGY VERSITREL
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 5357168
• MDR Text Key: 35534491
• Report Number: 3004209178-2016-00321
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2005
• Device Model Number: 7427V
• Device Catalogue Number: 7427V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2016
• Date Device Manufactured: 04/19/2004
• 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