MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Purulent Discharge (1812); Foreign Body Reaction (1868); Pain (1994); Irritability (2421)

Event Date 01/01/2003

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 7495-25, lot/serial#: (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 7495lz25, lot/serial#: (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 3487a, lot/serial#: (b)(4), product type: lead.Product id: 3487a, lot#serial#: (b)(4), product type: lead.Analysis results were not available at the time of this report.A follow up report will be sent once analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.The patient reported that her body rejected the device.The patient had a bad abscess.The patient reported that the device was implanted in her cheek of buttocks.The patient reported that it was irritated where it was because it kept getting hit.The patient reported that she used lidocaine but she couldn't bear the pain anymore.The patient reported that the ins was removed because the skin busted open and it was draining puss.No further complications were reported.

Manufacturer Narrative

Analysis of the ins (b)(4) found no significant anomalies.Product analysis #(b)(4).The implantable neurostimulator (ins) passed functional testing.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.The ins output was tested through the returned extension and lead.Good stable output was observed on all electrode pairs the ins had when it was received.The ins output was tested through the returned extension and lead.Good stable output was observed on all electrode pairs.The ins output was tested through the returned extension and cut lead.Good stable output was observed on all electrode pairs the ins had when it was received.The ins output was tested through the returned extension and cut lead.Good stable output was observed on all electrode pairs.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation: product id 7495-25 (b)(4) implanted: (b)(6)2002 product type extension product id 7495lz25 (b)(4) implanted: (b)(6)2002 product type extension product id 3487a lot# j0211651v product type lead product id 3487a lot# j0211651v product type lead all previously reported codes are still applicable.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.The patient reported that her body rejected the device.The patient had a bad abscess.The patient reported that the device was implanted in her cheek of buttocks.The patient reported that it was irritated where it was because it kept getting hit.The patient reported that she used lidocaine but she couldn¿t bear the pain anymore.The patient reported that the ins was removed because the skin busted open and it was draining puss.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.The patient stated that the reason their device abscessed was likely not due to the device, but rather the device location.The device was implanted in their butt, so whenever they sat, moved, bumped it the device was irritated.No further complications were reported or anticipated.

Manufacturer Narrative

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

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7802608
• MDR Text Key: 117791893
• Report Number: 1030489-2018-01156
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2003
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2012
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2002
• 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
• Patient Age: 47 YR
• Patient Weight: 103