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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Impaired Healing (2378); Fluid Discharge (2686)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. The patient reported drainage from the ins site, and upon inspection appeared serosanguineous in nature after a lead revision procedure in (b)(6) 2021. The was reduced upon clinic inspection; however, has not yet fully healed. A clinic visit was booked for further inspection on (b)(6) 2021. The site was examined to have serosanguinous discharge on (b)(6) 2021. Antibiotics were prescribed for an additional seven days. A sample of the drainage was sent to mic robiology for culture and sensitivity, and no bacteria growth was observed on (b)(6) 2021. On (b)(6) 2021, the patient reported ongoing discharge observed after antibiotic prescription despite increased wound healing.  examination on (b)(6) 2021 revealed no evidence of swelling or inflammation at the ins site. Another two weeks of antibiotics were prescribed.  examination on (b)(6) 2021 found that the edges of the wound appeared healthy, but there was a one centimeter gap that had not closed. The patient reported 1-2 cubic centimeters of discharge on a daily basis with daily dressing changes. The gap was closed with three staples after giving local anesthesia under aseptic conditions. The event was ongoing. The etiology was not related to the device or therapy, and related to the implant procedure, specifically to the ins pocket. The clinical diagnosis was delayed healing and drainage from the ins site, and a device diagnosis was not applicable. It was noted that the patient age was (b)(6) years at consent.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12365633
MDR Text Key268072275
Report Number3004209178-2021-12891
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial
Report Date 08/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2020
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/30/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/25/2021 Patient Sequence Number: 1
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